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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 K003704
Device Name OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
Applicant
OPTOVENT AB
1350 15TH STREET, SUITE 4H
FORT LEE,  NJ  07024
Applicant Contact CLAES RYMOND
Correspondent
OPTOVENT AB
1350 15TH STREET, SUITE 4H
FORT LEE,  NJ  07024
Correspondent Contact CLAES RYMOND
Regulation Number868.2375
Classification Product Code
BZQ  
Subsequent Product Code
DQA  
Date Received12/01/2000
Decision Date 02/05/2001
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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