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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 K871576
Device Name ROKONICS 8500
Applicant
ROKONICS, INC.
12950A WALSINGHAM RD.
LARGO,  FL  33544
Applicant Contact RICHARD E RUTH
Correspondent
ROKONICS, INC.
12950A WALSINGHAM RD.
LARGO,  FL  33544
Correspondent Contact RICHARD E RUTH
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/22/1987
Decision Date 07/16/1987
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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