Pinwheel
Regulation 882.1750
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GWY
| Company | 510(k)s | Recalls |
|---|---|---|
| Artiberia | 1 | 0 |
| Aspect Medical Systems, Inc. | 1 | 0 |
| Burke Neutech, Inc. | 1 | 0 |
| Dexin Pty. , Ltd. | 1 | 0 |
| Projects IN Health | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 2005 | K050313 | BIS SRS (SEMI-RESUABLE SENSOR) Aspect Medical Systems, Inc. | GWY |
| Aug 3, 1994 | K942926 | NEURO-AIDE Burke Neutech, Inc. | GWY |
| Apr 1, 1987 | K871167 | SENSITESTER Dexin Pty. , Ltd., AU | GWY |
| Jun 13, 1985 | K851749 | 1-380 PINWHEEL (WARTENBERG) Artiberia | GWY |
| Apr 4, 1978 | K780422 | PINWHEEL Projects IN Health | GWY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.