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510(k) K031515

SPIROPRO SPO2 by Viasys Healthcare GmbH — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
May 14, 2003
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 Viasys Healthcare GmbH

  • K092324 — SPIROPRO (September 3, 2009)
  • K091412 — CLEAN PEAK FLOW METER (August 21, 2009)
  • K091505 — COR12+ (June 10, 2009)
  • K081823 — MASTERSCREEN PAED - BABY BODY (May 18, 2009)
  • K080510 — VIP PULMONARY FUNCTION SYSTEM (August 20, 2008)
  • K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (June 26, 2008)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)
  • K071753 — MASTERSCREEN PNEUMO & MASTERSCOPE (August 14, 2007)
  • K062011 — MODIFICATION TO FLOWSCREEN (May 11, 2007)

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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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