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510(k) K901504

MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. by Ivy Biomedical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
March 29, 1990
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

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  • K091787 — MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (October 9, 2009)
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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)
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