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510(k) K013154

MARK II/MARK III MANOMETRIC PERFUSION PUMP by Dentsleeve Pty., Ltd. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2001
Date Received
September 20, 2001
Clearance Type
Special
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 Dentsleeve Pty., Ltd.

  • K983665 — MANOMETRIC ASSEMBLIES (May 17, 1999)
  • K980946 — MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP (June 8, 1998)

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