Omnispec ED1000

by Medispec, Ltd.

510(k) K210166

Omnispec ED1000 is a Class I device made by Medispec, Ltd., cleared under FDA 510(k) K210166 on 27 Jan 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K210166↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK210166	Date27 Jan 2023Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K210166

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K210166
FDA product code: ISA

Device class: Class I
Regulation: 21 CFR Part 890.5660
Advisory committee: Physical Medicine
FDA decision: SESE Substantially Equivalent

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