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FDA 510(k)

BLOM-SINGER LOW PRESSURE VOICE PROSTHES

K-Number: K842896 · 1984-08-17

ApplicantAmerican V. Mueller
Decision Date1984-08-17
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER LOW PRESSURE VOICE PROSTHES is the device name listed in this FDA 510(k) record. The listed applicant is American V. Mueller. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842896. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER LOW PRESSURE VOICE PROSTHES?

BLOM-SINGER LOW PRESSURE VOICE PROSTHES is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is American V. Mueller. The 510(k) number is K842896.

When did BLOM-SINGER LOW PRESSURE VOICE PROSTHES receive FDA 510(k) clearance?

BLOM-SINGER LOW PRESSURE VOICE PROSTHES received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842896.

Who is the listed applicant for BLOM-SINGER LOW PRESSURE VOICE PROSTHES?

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

What is the FDA product code for BLOM-SINGER LOW PRESSURE VOICE PROSTHES?

The FDA product code for BLOM-SINGER LOW PRESSURE VOICE PROSTHES is EWL.

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Related Devices (Code: EWL)

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.

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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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