QXYClass II
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
21 CFR 870.1135 / Cardiovascular
QXY is the FDA product code for Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature, a class II device type, regulated under 21 CFR 870.1135. FDA's definition for this code reads: "An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXY
- Device name
- Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
- FDA definition
- An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.
- Regulation
- 21 CFR 870.1135
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QXY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code QXY| Applicant | Clearances |
|---|---|
| Omron Healthcare Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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