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510(k) K002889

PNS MAGNETIC STIMULATOR SYSTEM by Neotonus, Inc. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2001
Date Received
September 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Neotonus, Inc.

  • K001903 — NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (August 29, 2000)
  • K973096 — NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM (June 12, 1998)
  • K973929 — NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM (May 21, 1998)

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