Home / 510(k) Clearances / K922838

510(k) K922838

NORODYN 2000 ELECTROMYOGRAPH by Noromed, Inc. — Product Code HCC

K922838 is an FDA 510(k) premarket notification submitted by Noromed, Inc. for the device "NORODYN 2000 ELECTROMYOGRAPH". The FDA issued a decision of Substantially Equivalent on September 22, 1993. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Noromed, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1993
Date Received
June 12, 1992
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 Noromed, Inc.

  • K920690 — NOROTRACK 360 INCLINOMETER (May 20, 1992)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • 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)

FDA data resources