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FDA 510(k)

MSCB-001

K-Number: K152274 · 2016-03-25

ApplicantGC America, Inc.
Decision Date2016-03-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MSCB-001 is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152274. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSCB-001?

MSCB-001 is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is GC America, Inc.. The 510(k) number is K152274.

When did MSCB-001 receive FDA 510(k) clearance?

MSCB-001 received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152274.

Who is the listed applicant for MSCB-001?

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

What is the FDA product code for MSCB-001?

The FDA product code for MSCB-001 is EIH.

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Related Devices (Code: EIH)

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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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