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510(k) K000794

MODIFICATION TO MARSPO2, MODEL 2001 by Novametrix Medical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2000
Date Received
March 13, 2000
Clearance Type
Special
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 Novametrix Medical Systems, Inc.

  • K010451 — NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (April 25, 2001)
  • K993979 — MARSPO2, MODEL 2001 (February 22, 2000)
  • K982499 — COSMO PLUS WITH NICO, MODEL 8200 (October 16, 1998)
  • K964360 — VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (April 4, 1997)
  • K963380 — CO 2 SMO PLUS (January 22, 1997)
  • K963327 — TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 (November 20, 1996)
  • K960831 — VENTRAK RMMS 1550 (May 29, 1996)
  • K924626 — NOVAMETRIX MODEL 510 (December 3, 1993)
  • K920379 — NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX (July 15, 1992)
  • K913516 — MODEL 520A NOVAMETRIX PULSE OXIMETER (November 4, 1991)

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  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • 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)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)