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510(k) K953642

AP-18 by Jeneric/Pentron, Inc. — Product Code JEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1995
Date Received
August 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

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  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

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