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FDA 510(k)

BERA SH 221 BRIAN STEM AUDIOMETER

K-Number: K830173 · 1983-05-25

ApplicantJedmed Instrument Co.
Decision Date1983-05-25
Product CodeGNJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BERA SH 221 BRIAN STEM AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K830173. The device is classified under product code GNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERA SH 221 BRIAN STEM AUDIOMETER?

BERA SH 221 BRIAN STEM AUDIOMETER is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K830173.

When did BERA SH 221 BRIAN STEM AUDIOMETER receive FDA 510(k) clearance?

BERA SH 221 BRIAN STEM AUDIOMETER received FDA 510(k) clearance on 1983-05-25, under 510(k) number K830173.

Who is the listed applicant for BERA SH 221 BRIAN STEM AUDIOMETER?

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

What is the FDA product code for BERA SH 221 BRIAN STEM AUDIOMETER?

The FDA product code for BERA SH 221 BRIAN STEM AUDIOMETER is GNJ.

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Other records listing Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

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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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