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510(k) K880581

AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. by Synectics-Dantec — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1988
Date Received
February 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
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