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510(k) K822272

HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS by Kelleher Corp. — Product Code HPQ

K822272 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code HPQ (Headlamp, Operating, Ac-Powered), a Class II device regulated under 21 CFR 886.4335. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1982
Date Received
July 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlamp, Operating, Ac-Powered
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

Other clearances by Kelleher Corp.

  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 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)
  • K822185 — LARYNGEAL SYRINGE (October 18, 1982)

Other clearances for product code HPQ

  • K952289 — WELCH ALLYN FIBER OPTIC HEADLIGNT (July 14, 1995)
  • K951337 — FIBER HEAD LIGHT FH-300 (June 8, 1995)
  • K861746 — KEELER DUAL LIGHTSOURCE (August 21, 1986)
  • K861747 — KEELER FIBEROPTIC HEADLAMP (August 21, 1986)

FDA data resources