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FDA 510(k)

SOLID GEL PAD

K-Number: K131905 · 2013-07-18

ApplicantBluemtech
Decision Date2013-07-18
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOLID GEL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Bluemtech. It received FDA 510(k) clearance on 2013-07-18 under 510(k) number K131905. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLID GEL PAD?

SOLID GEL PAD is a medical device that received FDA 510(k) clearance on 2013-07-18. The listed applicant is Bluemtech. The 510(k) number is K131905.

When did SOLID GEL PAD receive FDA 510(k) clearance?

SOLID GEL PAD received FDA 510(k) clearance on 2013-07-18, under 510(k) number K131905.

Who is the listed applicant for SOLID GEL PAD?

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

What is the FDA product code for SOLID GEL PAD?

The FDA product code for SOLID GEL PAD is MUI.

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Related Devices (Code: MUI)

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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