FDA 510(k)

OTE MPS 045 Multi-purpose Lens Care Solution

Numéro K : K210051 · 2021-05-26

Date de décision2021-05-26

Code produitLPN

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

OTE MPS 045 Multi-purpose Lens Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Ote North America, LLC. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K210051. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OTE MPS 045 Multi-purpose Lens Care Solution?

OTE MPS 045 Multi-purpose Lens Care Solution is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Ote North America, LLC. The 510(k) number is K210051.

When did OTE MPS 045 Multi-purpose Lens Care Solution receive FDA 510(k) clearance?

OTE MPS 045 Multi-purpose Lens Care Solution received FDA 510(k) clearance on 2021-05-26, under 510(k) number K210051.

Who is the listed applicant for OTE MPS 045 Multi-purpose Lens Care Solution?

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

What is the FDA product code for OTE MPS 045 Multi-purpose Lens Care Solution?

The FDA product code for OTE MPS 045 Multi-purpose Lens Care Solution is LPN.

Essais cliniques associés

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Source officielle

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