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510(k) K092675

GRINDCARE by Medotech A/S — Product Code HCC

K092675 is an FDA 510(k) premarket notification submitted by Medotech A/S for the device "GRINDCARE". The FDA issued a decision of Substantially Equivalent on March 3, 2010. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Medotech A/S has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2010
Date Received
September 1, 2009
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 Medotech A/S

  • K113677 — GRINDCARE MEASURE (April 5, 2012)

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)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources