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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K953642
Device Name AP-18
Applicant
JENERIC/PENTRON, INC.
125 N. PLAINS IND. RD.
WALLINGFORD,  CT  06492 -0724
Applicant Contact JOSEPH MACDOUGALD
Correspondent
JENERIC/PENTRON, INC.
125 N. PLAINS IND. RD.
WALLINGFORD,  CT  06492 -0724
Correspondent Contact JOSEPH MACDOUGALD
Regulation Number868.1760
Classification Product Code
JEH  
Date Received08/04/1995
Decision Date 12/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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