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FDA 510(k)

OT EQUATOR

K-Number: K160382 · 2016-08-11

ApplicantRhein'83 Srl
Decision Date2016-08-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OT EQUATOR is a medical device manufactured by Rhein'83 Srl. It received FDA 510(k) clearance on 2016-08-11 under approval number K160382. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OT EQUATOR?

OT EQUATOR is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Rhein'83 Srl. The 510(k) number is K160382.

When was OT EQUATOR approved by the FDA?

OT EQUATOR received FDA 510(k) clearance on 2016-08-11, under approval number K160382.

What company makes OT EQUATOR?

OT EQUATOR is manufactured by Rhein'83 Srl.

What is the FDA product code for OT EQUATOR?

The FDA product code for OT EQUATOR is NHA.

Other Devices by Rhein'83 Srl

K171409OT EQUATOR

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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