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Foot Switch A803

by Sontec Instruments, Inc.

Foot Switch A803 is a Class II device made by Sontec Instruments, Inc., cleared under FDA 510(k) K000961 on 19 Apr 2000 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI 00192896009219), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K000961

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192896009219 UDI-DI Date15 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK000961 Date19 Apr 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000961 decided 19 Apr 2000 Active
  • FDA GUDID UDI-DI 00192896009219 listed 15 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000961
  2. Listed FDA GUDID 00192896009219

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Foot Switch
Generic name
Foot-switch, electrical
Model / Ref / Catalog
A803
Primary DI / UDI-DI
00192896009219
510(k) Number
FDA product code
GEI
GMDN term
Foot-switch, electrical
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)