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FDA 510(k)

NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING

K-Number: K822269 · 1982-09-09

ApplicantKelleher Corp.
Decision Date1982-09-09
Product CodeEWC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-09-09 under 510(k) number K822269. The device is classified under product code EWC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING?

NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING is a medical device that received FDA 510(k) clearance on 1982-09-09. The listed applicant is Kelleher Corp.. The 510(k) number is K822269.

When did NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING receive FDA 510(k) clearance?

NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING received FDA 510(k) clearance on 1982-09-09, under 510(k) number K822269.

Who is the listed applicant for NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING?

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 NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING?

The FDA product code for NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING is EWC.

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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 UNITSK823111NYSTYMOGRAPH ACCESSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

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Related Devices (Code: EWC)

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.

K823872EMERGENCY TRACHEOSTOMY KITOmnicon Medical Corp.

Official Source

View on FDA Database →

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

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