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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plethysmograph, Impedance
510(k) Number K895588
Device Name PORTABLE AIR PLETHYSMOGRAPH
Applicant
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Applicant Contact GLYN GREEN
Correspondent
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Correspondent Contact GLYN GREEN
Regulation Number870.2770
Classification Product Code
DSB  
Date Received09/15/1989
Decision Date 03/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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