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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Airway Pressure (Inspiratory Force)
510(k) Number K912946
Device Name COLLINS DIGITAL PULMONARY MANOMETER
Applicant
Warren E. Collins, Inc.
220 Wood Rd.
Braintree,  MA  02184
Applicant Contact JAMES J TULLY
Correspondent
Warren E. Collins, Inc.
220 Wood Rd.
Braintree,  MA  02184
Correspondent Contact JAMES J TULLY
Regulation Number868.1780
Classification Product Code
BXR  
Date Received07/05/1991
Decision Date 01/15/1992
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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