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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K860933
Device Name AIR-CUSHION TOCOTONOMETER
Applicant
International Biomedics, Inc.
1631 220th Ave. SE
(Per Do, Firm Oob)
Bothell,  WA  98021
Applicant Contact HOWARD M HOCHBERG
Correspondent
International Biomedics, Inc.
1631 220th Ave. SE
(Per Do, Firm Oob)
Bothell,  WA  98021
Correspondent Contact HOWARD M HOCHBERG
Regulation Number884.2720
Classification Product Code
HFM  
Date Received03/12/1986
Decision Date 07/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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