BTK — Strap, Head, Gas Mask Class I
FDA product code BTK covers "Strap, Head, Gas Mask", a Class I medical device regulated under 21 CFR 868.5560. Submissions are reviewed by the Anesthesiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTK
- Device Class
- Class I
- Regulation Number
- 868.5560
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944949 | vital signs | GENERAL ANESTHESIA SYSTEM | November 14, 1994 |
| K914335 | vital signs | STRAP, HEAD, GAS MASK | April 2, 1992 |
| K854537 | life design systems | HEADSTRAP | December 3, 1985 |
| K853573 | medipart jerry alexander | MEDIPART FACE MASK HEADSTRAP MP-9100 | October 29, 1985 |
| K831008 | medovations | HEAD STRAP | May 9, 1983 |
| K810991 | respironics | HEADSTRAP | April 29, 1981 |