Panels › Anesthesiology › Product code BTK · Class 1
Strap, Head, Gas Mask
Regulation 868.5560
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in BTK
| Company | 510(k)s | Recalls |
|---|---|---|
| Vital Signs, Inc. | 2 | 0 |
| Life Design Systems, Inc. | 1 | 0 |
| Medipart Jerry Alexander | 1 | 0 |
| Medovations, Inc. | 1 | 0 |
| Respironics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 1994 | K944949 | GENERAL ANESTHESIA SYSTEM Vital Signs, Inc. | BTK |
| Apr 2, 1992 | K914335 | STRAP, HEAD, GAS MASK Vital Signs, Inc. | BTK |
| Dec 3, 1985 | K854537 | HEADSTRAP Life Design Systems, Inc. | BTK |
| Oct 29, 1985 | K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 Medipart Jerry Alexander | BTK |
| May 9, 1983 | K831008 | HEAD STRAP Medovations, Inc. | BTK |
| Apr 29, 1981 | K810991 | HEADSTRAP Respironics, Inc. | BTK |
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