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510(k) K955887

NEWMED ABP-LITE by Newmed Corp. — Product Code DXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1996
Date Received
December 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Phonocatheter, Intracavitary
Device Class
Class II
Regulation Number
870.1270
Review Panel
CV
Submission Type

Other clearances by Newmed Corp.

  • K935955 — DOSER (September 16, 1994)

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