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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Apnea, Facility Use
510(k) Number K894973
Device Name RESPITRACE PLUS
Applicant
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact RODNEY R MUNSEY
Correspondent
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact RODNEY R MUNSEY
Regulation Number868.2377
Classification Product Code
FLS  
Date Received08/07/1989
Decision Date 10/30/1989
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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