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7175-6100

by PENTAX of America Inc.

7175-6100 is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K990240 on 11 Mar 1999 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333230419), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K990240

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333230419 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK990240 Date11 Mar 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990240 decided 11 Mar 1999 Active
  • FDA GUDID UDI-DI 04961333230419 listed 7 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K990240
  2. Listed FDA GUDID 04961333230419

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Electroglottograph
Model / reference
7175-6100
Primary DI / UDI-DI
04961333230419
510(k) Number
FDA product code
KLX
GMDN term
Electroglottograph
Device class
Class II
Regulation number
874.1325
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroglottograph

Cleared under the same submission (K990240)

Similar devices

Other devices filed under FDA product code KLX (Electroglottograph).

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)