FDA lists separate product code entries for oximeters and oximeters intended for wellness use. Search the exact device and manufacturer record to check its specific classification and regulatory submission.
FDA’s classification database distinguishes an oximeter entry from a product code for an oximeter intended for wellness use. The product code describes a generic device category, so it does not identify the status of every model sold under a similar product name.
Classification entries to compare
| FDA product code | FDA device name | Record detail |
|---|---|---|
| DQA | Oximeter | Class II; submission type 510(k) |
| PGJ | Oximeter, wellness | Pulse oximeter intended for wellness use; FDA lists enforcement discretion as the submission type |
FDA’s DQA classification record and PGJ classification record describe these product-code categories. They are not device-specific decisions for every product with “oximeter” in its name.
Match a product to its record
- Record the exact product name, manufacturer, model, and claims from the product labeling.
- Search the FDA databases using the manufacturer’s name, device name, or submission number.
- Compare the matching device record with the product label and model.
- Check the product code, device class, submission type, and decision details.
- Read the indications and labeling for the exact record.
- Check for a separate entry when the product is described as a wellness device or as one feature in a larger product.
For a smartwatch feature with its own record, see what FDA records say about Apple Watch ECG. For another wearable category, read the FDA record for wearable fall-injury-prevention devices. Browse home monitors.
This page describes device classification and regulatory records. Speak with a doctor about health concerns or questions about using a medical device.
Sources
Common questions
Do all products called pulse oximeters have the same FDA product code?
No. FDA lists distinct product codes, including oximeter and wellness oximeter entries. Check the exact device record.
What does the DQA product code identify?
FDA's classification record identifies DQA as the product code for an oximeter.
Can I use a product code alone to identify a specific device?
No. Match the device name, manufacturer, product code, and record details together.