FDA 510(k)

Ova+ (K-OVAP-USA)

K-Number: K230926 · 2023-12-15

Decision Date2023-12-15

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Ova+ (K-OVAP-USA) is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-12-15 under approval number K230926. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ova+ (K-OVAP-USA)?

Ova+ (K-OVAP-USA) is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Tenscare, Ltd.. The 510(k) number is K230926.

When was Ova+ (K-OVAP-USA) approved by the FDA?

Ova+ (K-OVAP-USA) received FDA 510(k) clearance on 2023-12-15, under approval number K230926.

What company makes Ova+ (K-OVAP-USA)?

Ova+ (K-OVAP-USA) is manufactured by Tenscare, Ltd..

What is the FDA product code for Ova+ (K-OVAP-USA)?

The FDA product code for Ova+ (K-OVAP-USA) is NUH.

Other Devices by Tenscare, Ltd.

K191312Perfect PFE K200694Perfect EMS K230983Unicare (K-UNICARE-USA) K231053Unicare (K-UNICARE-USA) K232441Unipro (K-UNIPRO-US)

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Official Source

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