Hotdog Multi Function Controller

FDA 510(k) K094056 · Augustine Biomedical & Design, LLC

Substantially Equivalent

510(k) numberK094056

Submission

Device name
Hotdog Multi Function Controller
Applicant
Augustine Biomedical & Design, LLC
Eden Prairie, MN, US
Received
December 31, 2009
Decision date
June 3, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DWJ – System, Thermal Regulating
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5900
Specialty
Cardiovascular

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Hotdog Multi Function Controller cleared by the FDA?

Hotdog Multi Function Controller (K094056) received a 510(k) decision of Substantially Equivalent on June 3, 2010, 154 days after the submission was received.

What is the product code of K094056?

The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.