Skip to content

Sierra Summit 190280-200

by Cadwell Industries, Inc.

Sierra Summit 190280-200 is a Class II device made by Cadwell Industries, Inc., listed in FDA GUDID since 5 Sep 2016 (UDI-DI 00840067100097), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840067100097 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sierra Summit
Generic name
Electromyograph
Model / reference
190280-200
Primary DI / UDI-DI
00840067100097
FDA product code
GWQ, GWE, JXE, OLV, GWF, IKN, GWJ, OLT, GZP
GMDN term
Electromyograph
Device class
Class II
Regulation number
882.1400, 882.1890, 882.1550, 882.1870, 890.1375, 882.1900, 882.1880
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Sierra Summit

Related devices

Category: Electromyograph

Similar devices

Other devices filed under FDA product code GWQ (Full-montage Standard Electroencephalograph).

Other devices from Cadwell Industries, Inc.

See all devices from Cadwell Industries, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)