Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

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

510(k) Number

K082655 ↗

FDA Product Code

CCL

Models / Variants

Envitec Medical Oxygen Senors, Models OOM101

00M102/-1

OOM103/-1/-1M

OOM104

OOM105

00M106

Device Class

Class II

Regulation

21 CFR Part 868.1720

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Envitec Reusable Multi-Site Y SPO2 Sensors

  Class II

  FDA 510(k) K043463 Active Cleared 11 Feb 2005

• Reusable Envitec Finger SPO2 Sensor-Hp/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor

  Class II

  FDA 510(k) K090438 Active Cleared 24 Jul 2009

• Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped

  Class II

  FDA 510(k) K992215 Active Cleared 29 Mar 2000

• Envitec Reusable SPO2 Sensors Type Nihon-Kohden

  Class II

  FDA 510(k) K102270 Active Cleared 22 Feb 2011

• Envitec Oxipen Pulse Oximeter and Accessories

  Class II

  FDA 510(k) K070193 Active Cleared 2 May 2007

• Envitec Mysign O Oxygen Measuring Device

  Class II

  FDA 510(k) K122290 Active Cleared 23 Jan 2013

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