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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K851819
Device Name ROKONICS SENTRY MODEL 8500
Applicant
ROKONICS, INC.
12950A WALSINGHAM RD.
LARGO,  FL  33544
Applicant Contact JOHN SOROKO
Correspondent
ROKONICS, INC.
12950A WALSINGHAM RD.
LARGO,  FL  33544
Correspondent Contact JOHN SOROKO
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/26/1985
Decision Date 01/21/1986
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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