FDA 510(k)

HotDog Temperature Management Controller

K-Number: K201779 · 2020-09-11

ApplicantAugustine Temperature Management

Decision Date2020-09-11

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HotDog Temperature Management Controller is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201779. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HotDog Temperature Management Controller?

HotDog Temperature Management Controller is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Augustine Temperature Management. The 510(k) number is K201779.

When did HotDog Temperature Management Controller receive FDA 510(k) clearance?

HotDog Temperature Management Controller received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201779.

Who is the listed applicant for HotDog Temperature Management Controller?

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

What is the FDA product code for HotDog Temperature Management Controller?

The FDA product code for HotDog Temperature Management Controller is DWJ.

Other records listing Augustine Temperature Management 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 K210727HotDog Warming Mattress + Return Electrode

Related Devices (Code: DWJ)

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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.