BTK · Strap, Head, Gas Mask
Anesthesiology · 21 CFR 868.5560 · Class 1
Overview
| Product Code | BTK |
|---|---|
| Device Name | Strap, Head, Gas Mask |
| Regulation | 21 CFR 868.5560 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944949 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | Nov 14, 1994 | SESK |
| K914335 | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | Apr 2, 1992 | SESE |
| K854537 | HEADSTRAP | Life Design Systems, Inc. | Dec 3, 1985 | SESE |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K831008 | HEAD STRAP | Medovations, Inc. | May 9, 1983 | SESE |
| K810991 | HEADSTRAP | Respironics, Inc. | Apr 29, 1981 | SESE |
Top Applicants
- Vital Signs, Inc. — 2 clearances
- Respironics, Inc. — 1 clearance
- Medovations, Inc. — 1 clearance
- Medipart Jerry Alexander — 1 clearance
- Life Design Systems, Inc. — 1 clearance
