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FDA 510(k)

GEMINI CONDOR

K-Number: K081135 · 2008-04-29

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2008-04-29
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GEMINI CONDOR is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2008-04-29 under 510(k) number K081135. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMINI CONDOR?

GEMINI CONDOR is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K081135.

When did GEMINI CONDOR receive FDA 510(k) clearance?

GEMINI CONDOR received FDA 510(k) clearance on 2008-04-29, under 510(k) number K081135.

Who is the listed applicant for GEMINI CONDOR?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEMINI CONDOR?

The FDA product code for GEMINI CONDOR is KPS.

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Related Devices (Code: KPS)

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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