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510(k) K823872

EMERGENCY TRACHEOSTOMY KIT by Omnicon Medical Corp. — Product Code EWC

K823872 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "EMERGENCY TRACHEOSTOMY KIT". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code EWC (Chamber, Acoustic (For Audiometric Testing)), a Class I device regulated under 21 CFR 874.1060. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1983
Date Received
December 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Acoustic (For Audiometric Testing)
Device Class
Class I
Regulation Number
874.1060
Review Panel
EN
Submission Type

Other clearances by Omnicon Medical Corp.

  • K820576 — MAINFLOW BACTERIA FILTER (March 18, 1982)
  • K820577 — ANESTHESIA BACTERIA FILTER (March 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (August 13, 1980)
  • K801803 — MAINFLOW BACTERIA FILTER (August 13, 1980)
  • K772060 — PROTECT IV GARD (December 20, 1977)
  • K770136 — DISPOSABLE BACTERIA FILTER (February 14, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (January 12, 1977)
  • K760819 — CONDUCTIVE ANESTHESIA BREATHING CIRCUIT (October 27, 1976)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (July 19, 1976)

Other clearances for product code EWC

  • K822269 — NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING (September 9, 1982)

FDA data resources