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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K860692
Device Name PTR MK II VENTILATOR
Applicant
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Applicant Contact RAY PIZINGER
Correspondent
BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE,  CA  92507
Correspondent Contact RAY PIZINGER
Regulation Number868.5935
Classification Product Code
BYT  
Date Received02/25/1986
Decision Date 05/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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