Ambulatory Mark XI Drug Infusion Dev-

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K830657 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ambulatory Mark I

  Class II

  FDA 510(k) K822842 Active Cleared 24 Mar 1983

• Infusion Pump Access. #60-01-5

  Class I

  FDA 510(k) K830317 Active Cleared 31 Mar 1983

• Ambulatory Mark III Infusion Device

  Class II

  FDA 510(k) K830656 Active Cleared 16 Aug 1983

• Windsor Medical Various Models

  Class II

  FDA 510(k) K832606 Active Cleared 29 Nov 1983

• Windsor Medical Model 52

  Class II

  FDA 510(k) K832641 Active Cleared 4 Oct 1983

• Windsor Medical Model 50-00002

  Class II

  FDA 510(k) K841481 Active Cleared 21 May 1984

See all devices from Windsor Medical, Inc. →