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FDA 510(k)

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2

K-Number: K854533 · 1986-09-30

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1986-09-30
Product Code
DecisionSubstantially Equivalent

Device Summary

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 is the device name listed in this FDA 510(k) record. The listed applicant is Madsen Electronics (Canada) , Ltd.. It received FDA 510(k) clearance on 1986-09-30 under 510(k) number K854533. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2?

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 is a medical device that received FDA 510(k) clearance on 1986-09-30. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K854533.

When did SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 receive FDA 510(k) clearance?

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 received FDA 510(k) clearance on 1986-09-30, under 510(k) number K854533.

Who is the listed applicant for SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2?

The FDA 510(k) record lists Madsen Electronics (Canada) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Madsen Electronics (Canada) , Ltd. 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.

K942749HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENTK931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEMK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZER

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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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