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510(k) K133064

MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 by Envitec-Wismar GmbH — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2014
Date Received
September 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Envitec-Wismar GmbH

  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K102270 — ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN (February 22, 2011)
  • K090438 — REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414 (July 24, 2009)
  • K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM (November 25, 2008)
  • K070193 — ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES (May 2, 2007)
  • K060675 — ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS (July 17, 2006)
  • K043463 — ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (February 11, 2005)
  • K992215 — MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOS (March 29, 2000)

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  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
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  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
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