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510(k) K000831

STAT-SHELL DISPOSABLE SP02 SENSOR by Epic Medical Equipment Services, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2000
Date Received
March 14, 2000
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 Epic Medical Equipment Services, Inc.

  • K012333 — FLEXI-SITE SP02 EAR SENSOR (October 17, 2001)
  • K002848 — SPO2 WRAP SENSOR (May 24, 2001)
  • K010718 — FLEXI-SITE SP02 EAR SENSOR (March 23, 2001)
  • K002223 — EPIC SPO2 FINGER SENSOR, MODEL E412-20 (August 22, 2000)
  • K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (January 18, 2000)
  • K992211 — SPO2 WRAP SENSOR (December 22, 1999)
  • K992092 — STAT-SHELL DISPOSABLE SPO2 SENSOR (December 22, 1999)
  • K990082 — EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E (April 9, 1999)
  • K970098 — E100 SERIES SPO2 SENSORS (April 30, 1998)
  • K965172 — OXIMETER PRE-AMP CABLE (July 16, 1997)

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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)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)