LeadConfirm

• FDA 510(k) K191739 decided 2 Jan 2020 Active
• FDA GUDID UDI-DI 07290114060455 listed 4 Mar 2021 Listed

1. 2 Jan 2020 Cleared FDA 510(k) K191739
2. 4 Mar 2021 Listed FDA GUDID 07290114060455

Generic name

Electrical-only medical device connection cable, single-use

Model / Ref / Catalog

Sterile Neuro Omega LeadConfirm M Adaptor, STR-000071-10

Primary DI / UDI-DI

07290114060455

510(k) Number

K191739 ↗

FDA product code

GZL

GMDN term

Electrical-only medical device connection cable, single-use

Device class

Class II

Regulation number

882.1330

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Electrical-only medical device connection cable, single-use

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See all devices from Alpha Omega Engineering Corp. →