Skip to content

Single Dose Gas Injector

by Escalon Medical Trek 510(k)

Active United States

510(k) K923397

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923397 Date14 Sep 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BXX
Device Class
Class I
Regulation
21 CFR Part 868.2620
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent