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510(k) K952797

AT53 DUAL CHANNEL EMG by Stoelting Co. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1996
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Stoelting Co.

  • K012011 — MODIFICATION TO A620 EEG (October 10, 2001)
  • K965006 — AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) (February 5, 1997)
  • K944615 — A620 EEG (September 18, 1995)

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  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)