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510(k) K950687

EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) by Belmont Instrument Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
February 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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  • K032778 — LARGE VOLUME FLUID RESERVOIR (September 22, 2003)
  • K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (September 16, 2003)

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