Home / 510(k) Clearances / K822179

510(k) K822179

FRENZEL EYEGLASSES & RELATED ITEMS by Kelleher Corp. — Product Code KHH

K822179 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "FRENZEL EYEGLASSES & RELATED ITEMS". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code KHH (Stimulator, Caloric-Air), a Class I device regulated under 21 CFR 874.1800. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
July 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Air
Device Class
Class I
Regulation Number
874.1800
Review Panel
EN
Submission Type

Other clearances by Kelleher Corp.

  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
  • K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
  • K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
  • K822259 — LARYNGEAL SPATULAS (October 22, 1982)
  • K822004 — FACE SHIELDS (October 20, 1982)

Other clearances for product code KHH

  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K941325 — WATER IRRIGATOR, W1 200 (August 9, 1994)
  • K931608 — NCA-200 (June 22, 1993)
  • K925237 — AUTOMATIC CALORIC IRRIGATION SYSTEM (May 5, 1993)
  • K881630 — AUTOMATIC CALORIC IRRIGATION SYSTEM (June 21, 1988)

FDA data resources