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FDA 510(k)

Omnispec ED1000

K-Number: K210166 · 2023-01-27

ApplicantMedispec, Ltd.
Decision Date2023-01-27
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Omnispec ED1000 is a medical device manufactured by Medispec, Ltd.. It received FDA 510(k) clearance on 2023-01-27 under approval number K210166. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnispec ED1000?

Omnispec ED1000 is a medical device that received FDA 510(k) clearance on 2023-01-27. It is manufactured by Medispec, Ltd.. The 510(k) number is K210166.

When was Omnispec ED1000 approved by the FDA?

Omnispec ED1000 received FDA 510(k) clearance on 2023-01-27, under approval number K210166.

What company makes Omnispec ED1000?

Omnispec ED1000 is manufactured by Medispec, Ltd..

What is the FDA product code for Omnispec ED1000?

The FDA product code for Omnispec ED1000 is ISA.

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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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