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FDA 510(k)

FIT CHECKER ADVANCED

K-Number: K110871 · 2011-06-17

ApplicantGC America, Inc.
Decision Date2011-06-17
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIT CHECKER ADVANCED 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 2011-06-17 under 510(k) number K110871. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIT CHECKER ADVANCED?

FIT CHECKER ADVANCED is a medical device that received FDA 510(k) clearance on 2011-06-17. The listed applicant is GC America, Inc.. The 510(k) number is K110871.

When did FIT CHECKER ADVANCED receive FDA 510(k) clearance?

FIT CHECKER ADVANCED received FDA 510(k) clearance on 2011-06-17, under 510(k) number K110871.

Who is the listed applicant for FIT CHECKER ADVANCED?

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 FIT CHECKER ADVANCED?

The FDA product code for FIT CHECKER ADVANCED is ELW.

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Related Devices (Code: ELW)

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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