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510(k) K823111

NYSTYMOGRAPH ACCESS by Kelleher Corp. — Product Code GNN

K823111 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "NYSTYMOGRAPH ACCESS". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code GNN (Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6), a Class I device regulated under 21 CFR 866.3145. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
Device Class
Class I
Regulation Number
866.3145
Review Panel
MI
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)
  • 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)
  • K822185 — LARYNGEAL SYRINGE (October 18, 1982)

FDA data resources