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FDA 510(k)

EBM-500

K-Number: K840574 · 1985-11-14

ApplicantBosch Hearing Instruments, Inc.
Decision Date1985-11-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EBM-500 is the device name listed in this FDA 510(k) record. The listed applicant is Bosch Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K840574. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBM-500?

EBM-500 is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Bosch Hearing Instruments, Inc.. The 510(k) number is K840574.

When did EBM-500 receive FDA 510(k) clearance?

EBM-500 received FDA 510(k) clearance on 1985-11-14, under 510(k) number K840574.

Who is the listed applicant for EBM-500?

The FDA 510(k) record lists Bosch Hearing Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBM-500?

The FDA product code for EBM-500 is DXN.

Other records listing Bosch Hearing Instruments, Inc. 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.

K840571EKG 503AK840569EKG 501 AK822579BOSCH STAR 66F-SP HEARING AIDK820041BOSCH TOP STAR IIIK810347BOSCH STAR 66F SUPER EARLEVEL AIDK800779OMNITON MT80-A BODY HEARING AID

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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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