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FDA 510(k)

SUN MODEL OA 3000 OXYGEN ANALYZER

K-Number: K952941 · 1996-01-29

ApplicantSun Medical Equipment, Inc.
Decision Date1996-01-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUN MODEL OA 3000 OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Sun Medical Equipment, Inc.. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K952941. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUN MODEL OA 3000 OXYGEN ANALYZER?

SUN MODEL OA 3000 OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Sun Medical Equipment, Inc.. The 510(k) number is K952941.

When did SUN MODEL OA 3000 OXYGEN ANALYZER receive FDA 510(k) clearance?

SUN MODEL OA 3000 OXYGEN ANALYZER received FDA 510(k) clearance on 1996-01-29, under 510(k) number K952941.

Who is the listed applicant for SUN MODEL OA 3000 OXYGEN ANALYZER?

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

What is the FDA product code for SUN MODEL OA 3000 OXYGEN ANALYZER?

The FDA product code for SUN MODEL OA 3000 OXYGEN ANALYZER is CAW.

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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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