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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 K981725
Device Name OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
Applicant
Optovent, Inc.
1350 Fifteenth St.
Suite 4h
Fort Lee,  NJ  07024
Applicant Contact CLAES RYMOND
Correspondent
Optovent, Inc.
1350 Fifteenth St.
Suite 4h
Fort Lee,  NJ  07024
Correspondent Contact CLAES RYMOND
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/15/1998
Decision Date 02/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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