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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K892670
Device Name PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
Applicant
Physio-Dyne Instrument Corp.
35 Jeanette Dr.
P.O. Box 209
Massapequa,  NY  11758
Applicant Contact DONALD B FALK
Correspondent
Physio-Dyne Instrument Corp.
35 Jeanette Dr.
P.O. Box 209
Massapequa,  NY  11758
Correspondent Contact DONALD B FALK
Regulation Number868.1880
Classification Product Code
BZC  
Date Received04/13/1989
Decision Date 09/22/1989
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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