FDA 510(k)

sOLVe Tube

K-Nummer: K201026 · 2021-08-10

Entscheidungsdatum2021-08-10

ProduktcodeCBI

BeratungsausschussAN

EntscheidungSubstantially Equivalent

Produktübersicht

sOLVe Tube is the device name listed in this FDA 510(k) record. The listed applicant is Hytek Medical, Inc.. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K201026. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the sOLVe Tube?

sOLVe Tube is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Hytek Medical, Inc.. The 510(k) number is K201026.

When did sOLVe Tube receive FDA 510(k) clearance?

sOLVe Tube received FDA 510(k) clearance on 2021-08-10, under 510(k) number K201026.

Who is the listed applicant for sOLVe Tube?

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

What is the FDA product code for sOLVe Tube?

The FDA product code for sOLVe Tube is CBI.

Zugehörige klinische Studien

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Verwandte Geräte (Code: CBI)

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