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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
Predetermined Change
Control Plan Authorized		 No
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