Strap, Head, Gas Mask
FDA product code BTK · Class I (low risk) · 21 CFR 868.5560 · Anesthesiology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944949 | General Anesthesia SystemBTK · Traditional | Vital Signs, Inc. | 11/14/1994SESK |
| K914335 | Strap, Head, Gas MaskBTK · Traditional | Vital Signs, Inc. | 04/02/1992SE |
| K854537 | HeadstrapBTK · Traditional | Life Design Systems, Inc. | 12/03/1985SE |
| K853573 | Medipart Face Mask Headstrap MP-9100BTK · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K831008 | Head StrapBTK · Traditional | Medovations, Inc. | 05/09/1983SE |
| K810991 | HeadstrapBTK · Traditional | Respironics, Inc. | 04/29/1981SE |