Skip to content

Inhalation Operated Nebulizer Code

by Travenol Laboratories, S.A.

510(k) K791218

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

Forced Air Flow Nebulizer devices provide a reliable and effective means of delivering medication to patients in controlled environments. Our inhalation operated nebulizers offer superior ease of use, increased accuracy, and enhanced patient comfort.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791218 Date30 Jul 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Travenol Laboratories, S.A.

See all devices from Travenol Laboratories, S.A. →