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 the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) 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. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K210727.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

The FDA 510(k) record lists Augustine Temperature Management, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Augustine Temperature Management, LLC as applicant

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.

K232627HotDog Warming Mattress + Return Electrode K230866HotDog Warming Mattress + Return Electrode K220941HotDog Temperature Management System K201779HotDog Temperature Management Controller

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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.