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510(k) K822523

LARYNGOSTROBOSCOPE by Kelleher Corp. — Product Code EQL

K822523 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "LARYNGOSTROBOSCOPE". The FDA issued a decision of Substantially Equivalent on September 9, 1982. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1982
Date Received
August 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
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 EQL

  • K984521 — RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (March 17, 1999)
  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)
  • K921285 — 9105 RIGID TELESCOPIC ENDOSCOPE (May 28, 1992)
  • K884933 — ENDOSTROBOSCOPE IV (February 15, 1989)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)
  • K801866 — PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (September 16, 1980)
  • K770466 — STOCKINGS, RVS TM (March 28, 1977)

FDA data resources