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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 K854956
Device Name RESPIGRAPH
Applicant
Respitrace Corp.
C/O Dickstein, Shapiro & Morin
2101 L St., NW
Washington,  DC  20037
Applicant Contact RODNEY R MUNSEY
Correspondent
Respitrace Corp.
C/O Dickstein, Shapiro & Morin
2101 L St., NW
Washington,  DC  20037
Correspondent Contact RODNEY R MUNSEY
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/11/1985
Decision Date 03/20/1986
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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