FDA 510(k)

MaxiTears Contacts PF

Número K: K182984 · 2019-07-24

Data da decisão2019-07-24

Código do produtoMRC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

MaxiTears Contacts PF is the device name listed in this FDA 510(k) record. The listed applicant is Omnivision AG. It received FDA 510(k) clearance on 2019-07-24 under 510(k) number K182984. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MaxiTears Contacts PF?

MaxiTears Contacts PF is a medical device that received FDA 510(k) clearance on 2019-07-24. The listed applicant is Omnivision AG. The 510(k) number is K182984.

When did MaxiTears Contacts PF receive FDA 510(k) clearance?

MaxiTears Contacts PF received FDA 510(k) clearance on 2019-07-24, under 510(k) number K182984.

Who is the listed applicant for MaxiTears Contacts PF?

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

What is the FDA product code for MaxiTears Contacts PF?

The FDA product code for MaxiTears Contacts PF is MRC.

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