FDA 510(k) Applications for Medical Device Product Code "BTK"
(Strap, Head, Gas Mask)

FDA 510(k) Number Applicant Device Name Decision Date
K854537 LIFE DESIGN SYSTEMS, INC. HEADSTRAP 12/03/1985
K853573 MEDIPART JERRY ALEXANDER MEDIPART FACE MASK HEADSTRAP MP-9100 10/29/1985
K831008 MEDOVATIONS, INC. HEAD STRAP 05/09/1983
K810991 RESPIRONICS, INC. HEADSTRAP 04/29/1981
K944949 VITAL SIGNS, INC. GENERAL ANESTHESIA SYSTEM 11/14/1994
K914335 VITAL SIGNS, INC. STRAP, HEAD, GAS MASK 04/02/1992


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