Envitec Oxipen Pulse Oximeter and Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K070193 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

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 Mysign O Oxygen Measuring Device

  Class II

  FDA 510(k) K122290 Active Cleared 23 Jan 2013

• Mysign S Pulse Oximeter, Mysign Pc Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31

  Class II

  FDA 510(k) K133064 Active Cleared 2 May 2014

See all devices from Envitec-Wismar GmbH →