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FDA 510(k)

PORTABLE OXYGEN UNIT SCA900

K-Number: K080243 · 2009-04-07

ApplicantSan Cheong Co. , Ltd.
Decision Date2009-04-07
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN UNIT SCA900 is the device name listed in this FDA 510(k) record. The listed applicant is San Cheong Co. , Ltd.. It received FDA 510(k) clearance on 2009-04-07 under 510(k) number K080243. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE OXYGEN UNIT SCA900?

PORTABLE OXYGEN UNIT SCA900 is a medical device that received FDA 510(k) clearance on 2009-04-07. The listed applicant is San Cheong Co. , Ltd.. The 510(k) number is K080243.

When did PORTABLE OXYGEN UNIT SCA900 receive FDA 510(k) clearance?

PORTABLE OXYGEN UNIT SCA900 received FDA 510(k) clearance on 2009-04-07, under 510(k) number K080243.

Who is the listed applicant for PORTABLE OXYGEN UNIT SCA900?

The FDA 510(k) record lists San Cheong Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE OXYGEN UNIT SCA900?

The FDA product code for PORTABLE OXYGEN UNIT SCA900 is CAN.

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Related Devices (Code: CAN)

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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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