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FDA 510(k)

EleGARD

K-Number: K221901 · 2022-07-29

ApplicantAdvancedcpr Solutions, LLC
Decision Date2022-07-29
Product CodeFOA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EleGARD is the device name listed in this FDA 510(k) record. The listed applicant is Advancedcpr Solutions, LLC. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K221901. The device is classified under product code FOA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EleGARD?

EleGARD is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Advancedcpr Solutions, LLC. The 510(k) number is K221901.

When did EleGARD receive FDA 510(k) clearance?

EleGARD received FDA 510(k) clearance on 2022-07-29, under 510(k) number K221901.

Who is the listed applicant for EleGARD?

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

What is the FDA product code for EleGARD?

The FDA product code for EleGARD is FOA.

Related Devices (Code: FOA)

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.

K191689EleGARD Patient Positioning SystemMinnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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