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510(k) K963064

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM by Laborie Medical Tech Corp. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1997
Date Received
August 7, 1996
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

Other clearances by Laborie Medical Tech Corp.

  • K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (November 29, 1999)
  • K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES (August 5, 1999)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K950016 — CART, MODE NUMBER UDS-CART (March 30, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)

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