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FDA 510(k)

GERATHERM SOS-RESCUE BAG

K-Number: K051336 · 2006-06-29

ApplicantR.G. Enterprises, Inc.
Decision Date2006-06-29
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GERATHERM SOS-RESCUE BAG is the device name listed in this FDA 510(k) record. The listed applicant is R.G. Enterprises, Inc.. It received FDA 510(k) clearance on 2006-06-29 under 510(k) number K051336. 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 GERATHERM SOS-RESCUE BAG?

GERATHERM SOS-RESCUE BAG is a medical device that received FDA 510(k) clearance on 2006-06-29. The listed applicant is R.G. Enterprises, Inc.. The 510(k) number is K051336.

When did GERATHERM SOS-RESCUE BAG receive FDA 510(k) clearance?

GERATHERM SOS-RESCUE BAG received FDA 510(k) clearance on 2006-06-29, under 510(k) number K051336.

Who is the listed applicant for GERATHERM SOS-RESCUE BAG?

The FDA 510(k) record lists R.G. Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERATHERM SOS-RESCUE BAG?

The FDA product code for GERATHERM SOS-RESCUE BAG is 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.

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