BTK · Class I · 21 CFR 868.5560

FDA Product Code BTK: Strap, Head, Gas Mask

Leading manufacturers include Vital Signs, Inc., Respironics, Inc. and Medovations, Inc..

6
Total
6
Cleared
61d
Avg days
1981
Since

FDA 510(k) Cleared Strap, Head, Gas Mask Devices (Product Code BTK)

6 devices
1–6 of 6
Cleared Nov 14, 1994
GENERAL ANESTHESIA SYSTEM
K944949
Vital Signs, Inc.
Anesthesiology · 38d
Cleared Apr 02, 1992
STRAP, HEAD, GAS MASK
K914335
Vital Signs, Inc.
Anesthesiology · 188d
Cleared Dec 03, 1985
HEADSTRAP
K854537
Life Design Systems, Inc.
Anesthesiology · 20d
Cleared Oct 29, 1985
MEDIPART FACE MASK HEADSTRAP MP-9100
K853573
Medipart Jerry Alexander
Anesthesiology · 64d
Cleared May 09, 1983
HEAD STRAP
K831008
Medovations, Inc.
Anesthesiology · 40d
Cleared Apr 29, 1981
HEADSTRAP
K810991
Respironics, Inc.
Anesthesiology · 16d

About Product Code BTK - Regulatory Context