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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, monitoring (w/wo alarm)
510(k) Number K864886
Device Name RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
Applicant
NIMS/RESPITRACE CORP.
DICKSTEIN, SHAPIRO & MORIN
2101 L STREET, N.W.
WASHINGTON,  DC  20037
Applicant Contact RODNEY R MUNSEY
Correspondent
NIMS/RESPITRACE CORP.
DICKSTEIN, SHAPIRO & MORIN
2101 L STREET, N.W.
WASHINGTON,  DC  20037
Correspondent Contact RODNEY R MUNSEY
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/12/1986
Decision Date 03/06/1987
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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