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FDA 510(k)

NYSTYMOGRAPH ACCESS

K-Number: K823111 · 1982-11-22

ApplicantKelleher Corp.
Decision Date1982-11-22
Product CodeGNN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NYSTYMOGRAPH ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823111. The device is classified under product code GNN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYSTYMOGRAPH ACCESS?

NYSTYMOGRAPH ACCESS is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Kelleher Corp.. The 510(k) number is K823111.

When did NYSTYMOGRAPH ACCESS receive FDA 510(k) clearance?

NYSTYMOGRAPH ACCESS received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823111.

Who is the listed applicant for NYSTYMOGRAPH ACCESS?

The FDA 510(k) record lists Kelleher Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYSTYMOGRAPH ACCESS?

The FDA product code for NYSTYMOGRAPH ACCESS is GNN.

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Other records listing Kelleher Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETK822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPHK823083ELECTROSURGICAL UNITK822252ENT TREATMENT UNITSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDSK822017TYMPANOSTOMY TUBES & VARIOUS TYPES

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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