Caleo

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K003067 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sola 700, Sola 500, Sola 300

  Class II

  FDA 510(k) K010724 Active Cleared 7 Jun 2001

• Oxylog 1000, Model 2M86840

  Class II

  FDA 510(k) K010793 Active Cleared 20 Dec 2001

• Non-Invasive Ventilation NIV Option, Model 84 14 474

  Class II

  FDA 510(k) K010093 Active Cleared 14 Jun 2001

• Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072

  Class II

  FDA 510(k) K023289 Active Cleared 15 Jan 2003

• Drager Sola Series, Models 1000/700/500/300

  Class II

  FDA 510(k) K984611 Active Cleared 29 Mar 1999

• Ventview, Model 8414095

  Class II

  FDA 510(k) K012177 Active Cleared 4 Sep 2001

See all devices from Drager Medizintechnik GmbH →