GWY
5 FDA 510(k) clearances · Product code
18 daysmedian time to decision
49 days90th percentile
5clearances measured
FDA profile
- Official device name
- Pinwheel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 882.1750
- Medical specialty
- Neurology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIS SRS (SEMI-RESUABLE SENSOR) (K050313) | Aspect Medical Systems, Inc. | 2005-02-24 |
| NEURO-AIDE (K942926) | Burke Neutech, Inc. | 1994-08-03 |
| SENSITESTER (K871167) | Dexin Pty. , Ltd. | 1987-04-01 |
| 1-380 PINWHEEL (WARTENBERG) (K851749) | Artiberia | 1985-06-13 |
| PINWHEEL (K780422) | Projects IN Health | 1978-04-04 |
Track GWY automatically
Every clearance here is in the API, with alerts when new ones post.