Modification to Ivent 101

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

510(k) Number

K092135 ↗

FDA Product Code

CBK

FDA applicant

Versamed Medical Systems , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to: Ivent 201 Portable Ventilator

  Class II

  FDA 510(k) K052554 Active Cleared 23 Sep 2005

• Ivent 2001 MRI Conditional

  Class II

  FDA 510(k) K073694 Active Cleared 30 May 2008

• IVENT101

  Class II

  FDA 510(k) K112754 Active Cleared 15 Jun 2012

• Modification to I Vent 201

  Class II

  FDA 510(k) K061627 Active Cleared 29 Jun 2006

• Ivent 201

  Class II

  FDA 510(k) K053270 Active Cleared 27 Jan 2006

• Ivent 201 Portable Ventilator

  Class II

  FDA 510(k) K042468 Active Cleared 17 Nov 2004

See all devices from Versamed Medical Systems, Ltd. →