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510(k) K972419

TOENNIES NEUROSCREEN SYSTEM by Erich Jaeger, Inc. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
June 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

Other clearances by Erich Jaeger, Inc.

  • K023120 — OXYCON MOBILE (November 12, 2003)
  • K023796 — MS PAED-BABY BODY (March 3, 2003)
  • K021138 — SLEEPSCREEN/APNOESCREEN CARDIO (February 12, 2003)
  • K000396 — APNOESCREEN PRO, ALPHA SCREEN PRO (December 27, 2000)
  • K001502 — AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (July 12, 2000)
  • K000648 — SPIRO PRO (March 29, 2000)
  • K992214 — OXYCON PRO (February 22, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K980094 — MODIFICATION TO THE OXYCONALPHA (July 28, 1998)
  • K960078 — ASTHMA MONITOR (September 20, 1996)

Other clearances for product code IKN

  • K172743 — Natus VikingQuest (December 19, 2017)
  • K163150 — ViMove2 (July 14, 2017)
  • K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent (March 1, 2017)
  • K142494 — ViMove (May 28, 2015)
  • K131094 — VIMOVE (July 11, 2014)
  • K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (September 13, 2013)
  • K123399 — MYOVISION 3.0 WIREFREE SYSTEM (August 1, 2013)
  • K113074 — CMAP PRO (February 2, 2012)
  • K102610 — FOCUS EMG DEVICE (March 4, 2011)
  • K110048 — CERSR ELECTROMYOGRAPHY SYSTEM (January 26, 2011)