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FDA 510(k)

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)

K-Number: K121659 · 2013-04-18

ApplicantArcos, Inc.
Decision Date2013-04-18
Product CodePDT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) is the device name listed in this FDA 510(k) record. The listed applicant is Arcos, Inc.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K121659. The device is classified under product code PDT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)?

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Arcos, Inc.. The 510(k) number is K121659.

When did BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) receive FDA 510(k) clearance?

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) received FDA 510(k) clearance on 2013-04-18, under 510(k) number K121659.

Who is the listed applicant for BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)?

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

What is the FDA product code for BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)?

The FDA product code for BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) is PDT.

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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.

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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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