FDA 510(k)

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

Numéro K : K234153 · 2024-09-18

Date de décision2024-09-18

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is the device name listed in this FDA 510(k) record. The listed applicant is Edgelife Technologies, LLC. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K234153. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Edgelife Technologies, LLC. The 510(k) number is K234153.

When did EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) receive FDA 510(k) clearance?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) received FDA 510(k) clearance on 2024-09-18, under 510(k) number K234153.

Who is the listed applicant for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

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

What is the FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

The FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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