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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K925052
Device Name QA PRESSURE MEASUREMENT SYSTEM
Applicant
Gabel Medical Instruments, Ltd.
4243 Glanford Ave.
Victoria, Prov. B.C.,  CA V8Z 4B9
Applicant Contact LARA FARRIS
Correspondent
Gabel Medical Instruments, Ltd.
4243 Glanford Ave.
Victoria, Prov. B.C.,  CA V8Z 4B9
Correspondent Contact LARA FARRIS
Regulation Number890.1600
Classification Product Code
JFC  
Date Received10/06/1992
Decision Date 03/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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