FDA 510(k)

HotDog Warming Mattress + Return Electrode

K-Number: K210727 · 2022-02-01

ApplicantAugustine Temperature Management, LLC

Decision Date2022-02-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HotDog Warming Mattress + Return Electrode is a medical device manufactured by Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2022-02-01 under approval number K210727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2022-02-01. It is manufactured by Augustine Temperature Management, LLC. The 510(k) number is K210727.

When was HotDog Warming Mattress + Return Electrode approved by the FDA?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2022-02-01, under approval number K210727.

What company makes HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is manufactured by Augustine Temperature Management, LLC.

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is GEI.

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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.