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FDA 510(k)

BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING

K-Number: K092903 · 2009-12-01

ApplicantMaquet GmbH and Co. KG
Decision Date2009-12-01
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING is the device name listed in this FDA 510(k) record. The listed applicant is Maquet GmbH and Co. KG. It received FDA 510(k) clearance on 2009-12-01 under 510(k) number K092903. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING?

BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING is a medical device that received FDA 510(k) clearance on 2009-12-01. The listed applicant is Maquet GmbH and Co. KG. The 510(k) number is K092903.

When did BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING receive FDA 510(k) clearance?

BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING received FDA 510(k) clearance on 2009-12-01, under 510(k) number K092903.

Who is the listed applicant for BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING?

The FDA 510(k) record lists Maquet GmbH and Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING?

The FDA product code for BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING is BTA.

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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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Related Devices (Code: BTA)

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

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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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