FDA 510(k)

QUATERA 700

N.º K: K230858 · 2023-07-31

Fecha de decisión2023-07-31

Código de productoHQC

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

QUATERA 700 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K230858. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the QUATERA 700?

QUATERA 700 is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K230858.

When did QUATERA 700 receive FDA 510(k) clearance?

QUATERA 700 received FDA 510(k) clearance on 2023-07-31, under 510(k) number K230858.

Who is the listed applicant for QUATERA 700?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUATERA 700?

The FDA product code for QUATERA 700 is HQC.

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Otros registros que enlistan a Carl Zeiss Meditec, AG como solicitante

K260694ZEISS CLINIC 360 K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)K233911VISULAS combi K240215BLUE 400; BLUE 400 S K233421RESCAN 700 K232944CALLISTO eye

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Fuente oficial

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