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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K792516
Device Name RESPIRATOR DISCONNECT ALARM CR 201
Applicant
INTERSECT MEDICAL PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INTERSECT MEDICAL PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2600
Classification Product Code
CAP  
Date Received12/05/1979
Decision Date 01/09/1980
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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