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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 K902104
Device Name ORION WATCHGUARD
Applicant
Orion Industries
12811 Kenwood Ln., Suite 203
Fort Myers,  FL  33907
Applicant Contact BOB GRANTHAM
Correspondent
Orion Industries
12811 Kenwood Ln., Suite 203
Fort Myers,  FL  33907
Correspondent Contact BOB GRANTHAM
Regulation Number884.2720
Classification Product Code
HFM  
Date Received05/08/1990
Decision Date 10/25/1990
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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