FDA 510(k)

Omnispec ED1000

K-Number: K210166 · 2023-01-27

Decision Date2023-01-27

Product CodeISA

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Omnispec ED1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medispec, Ltd.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) 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. The listed applicant is Medispec, Ltd.. The 510(k) number is K210166.

When did Omnispec ED1000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Omnispec ED1000?

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

What is the FDA product code for Omnispec ED1000?

The FDA product code for Omnispec ED1000 is ISA.

Related Devices (Code: ISA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243488VMAT PROTermosalud K240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt K220538DolorClast RadialE.M.S Electro Medical Systems S.A K210451OrthoGold 100Tissue Regeneration Technologies, LLC

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.