FDA 510(k)

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

K-Number: K122610 · 2013-08-05

Decision Date2013-08-05

Product CodeBYE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sen MU Technology Co., Ltd.. It received FDA 510(k) clearance on 2013-08-05 under 510(k) number K122610. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES is a medical device that received FDA 510(k) clearance on 2013-08-05. The listed applicant is Sen MU Technology Co., Ltd.. The 510(k) number is K122610.

When did PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES receive FDA 510(k) clearance?

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES received FDA 510(k) clearance on 2013-08-05, under 510(k) number K122610.

Who is the listed applicant for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

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

What is the FDA product code for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

The FDA product code for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES is BYE.

Related Clinical Trials

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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.