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510(k) K843712

AUDIT TM V by Axonics, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1985
Date Received
September 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Axonics, Inc.

  • K833298 — AUDIT V AX 135 (December 1, 1983)
  • K831870 — ALLERGENETICS FLUORO-FAST READER (August 12, 1983)
  • K822335 — AUDIT (February 7, 1983)
  • K823494 — TOTAL IGE-FAST TEST (January 14, 1983)

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