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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K863087
Device Name SPIROLOOP-PULMONARY EXERCISE SYSTEM
Applicant
Pneumedics, Inc.
25 Van Zant St.
Norwalk,  CT  06855
Applicant Contact RICHARD P IMBRUCE
Correspondent
Pneumedics, Inc.
25 Van Zant St.
Norwalk,  CT  06855
Correspondent Contact RICHARD P IMBRUCE
Regulation Number868.1890
Classification Product Code
BTY  
Date Received08/12/1986
Decision Date 10/27/1986
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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