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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 K894667
Device Name MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
Applicant
Pneumedics, Inc.
291 Pepe'S Fram Rd.
Milford,  CT  06460
Applicant Contact P IMBRUCE
Correspondent
Pneumedics, Inc.
291 Pepe'S Fram Rd.
Milford,  CT  06460
Correspondent Contact P IMBRUCE
Regulation Number868.1890
Classification Product Code
BTY  
Date Received07/25/1989
Decision Date 10/19/1989
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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