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FDA 510(k)

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF

K-Number: K894826 · 1990-02-28

Decision Date1990-02-28
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1990-02-28 under 510(k) number K894826. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF?

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF is a medical device that received FDA 510(k) clearance on 1990-02-28. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K894826.

When did UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF receive FDA 510(k) clearance?

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF received FDA 510(k) clearance on 1990-02-28, under 510(k) number K894826.

Who is the listed applicant for UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF?

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

What is the FDA product code for UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF?

The FDA product code for UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF is DTZ.

Related Clinical Trials

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.

Other records listing Bentley Laboratories, 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.

View all 55 devices →

Related Devices (Code: DTZ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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