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FDA 510(k)

LOW PRESSURE BLOM-SINGER VOICE PROSTHES

K-Number: K823749 · 1983-01-07

ApplicantBivona Medical Technologies
Decision Date1983-01-07
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LOW PRESSURE BLOM-SINGER VOICE PROSTHES is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823749. 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 LOW PRESSURE BLOM-SINGER VOICE PROSTHES?

LOW PRESSURE BLOM-SINGER VOICE PROSTHES is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Bivona Medical Technologies. The 510(k) number is K823749.

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

LOW PRESSURE BLOM-SINGER VOICE PROSTHES received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823749.

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

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Bivona Medical Technologies as applicant

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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.

K240763FirstFit Surgical KitFreudenberg Medical, LLCK131947PROVOX VEGA PUNCTURE SETAtos Medical ABK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical ABK093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLCK090455PROVOX VEGA, MODEL 8130-8135Atos Medical ABK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC

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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