FDA 510(k)

Mouth Guard (ATG0603R)

K-Nummer: K231865 · 2023-11-06

Entscheidungsdatum2023-11-06

ProduktcodeOBR

EntscheidungSubstantially Equivalent

Produktübersicht

Mouth Guard (ATG0603R) is the device name listed in this FDA 510(k) record. The listed applicant is Reazeal Corp. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231865. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Mouth Guard (ATG0603R)?

Mouth Guard (ATG0603R) is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Reazeal Corp. The 510(k) number is K231865.

When did Mouth Guard (ATG0603R) receive FDA 510(k) clearance?

Mouth Guard (ATG0603R) received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231865.

Who is the listed applicant for Mouth Guard (ATG0603R)?

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

What is the FDA product code for Mouth Guard (ATG0603R)?

The FDA product code for Mouth Guard (ATG0603R) is OBR. This falls under the Orthopedic category.

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Verwandte Geräte (Code: OBR)

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