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510(k) K973929

NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM by Neotonus, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1998
Date Received
October 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Neotonus, Inc.

  • K002889 — PNS MAGNETIC STIMULATOR SYSTEM (April 6, 2001)
  • K001903 — NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (August 29, 2000)
  • K973096 — NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM (June 12, 1998)

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