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510(k) K810379

EARETTE HEARING AID SEARS #8054 by Oticon Corp. — Product Code FSD

K810379 is an FDA 510(k) premarket notification submitted by Oticon Corp. for the device "EARETTE HEARING AID SEARS #8054". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code FSD (Binder, Abdominal), a Class I device regulated under 21 CFR 880.5160. Oticon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
February 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Binder, Abdominal
Device Class
Class I
Regulation Number
880.5160
Review Panel
HO
Submission Type

Other clearances by Oticon Corp.

  • K133308 — TINNITUS SOUNDSUPPORT (March 18, 2014)
  • K973885 — OTICON DIGISOUND ITE (November 4, 1997)
  • K973886 — OTICON DIGISOUND COMPACT (November 4, 1997)
  • K964683 — DIGIFOCUS ITE (December 12, 1996)
  • K963788 — PRIMOFOCUS COMPACT (November 27, 1996)
  • K961059 — DIGIFOCUS COMPACT (May 7, 1996)
  • K960284 — OTICON /PRIMOFOCUS (PF) (March 7, 1996)
  • K954794 — OTICON (November 13, 1995)
  • K951002 — AMENDMENTS TO MULTIFOCUS (September 18, 1995)
  • K950381 — OTICON/LOGIC (February 27, 1995)

Other clearances for product code FSD

  • K892379 — THE POUCH GROIN & ABDOMINAL STRESS AID (July 20, 1989)
  • K822817 — DOCE ALL-IN-THE-EAR AID (January 18, 1983)
  • K770162 — MATERNITY SUPPORTER (February 9, 1977)
  • K760772 — DISPOSABLE ABDOMINAL BINDER (November 3, 1976)

FDA data resources