Strap, Head, Gas Mask
The Strap, Head, Gas Mask is an accessory device consisting of straps or harnesses used to secure an anesthetic or oxygen gas mask in place against a patient's face during clinical use. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BTK, regulated under 21 CFR 868.5560 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BTK
- Device Class
- FDA class 1
- Regulation Number
- 868.5560
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944949 | GENERAL ANESTHESIA SYSTEM | Nov 14, 1994 | Unknown | Vital Signs, Inc. |
| K914335 | STRAP, HEAD, GAS MASK | Apr 02, 1992 | Substantially Equivalent | Vital Signs, Inc. |
| K854537 | HEADSTRAP | Dec 03, 1985 | Substantially Equivalent | Life Design Systems, Inc. |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Oct 29, 1985 | Substantially Equivalent | Medipart Jerry Alexander |
| K831008 | HEAD STRAP | May 09, 1983 | Substantially Equivalent | Medovations, Inc. |
| K810991 | HEADSTRAP | Apr 29, 1981 | Substantially Equivalent | Respironics, Inc. |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.