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510(k) K911191

PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR by Palco Laboratories, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
March 18, 1991
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 Palco Laboratories, Inc.

  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K943842 — PULSE OXIMETER MODEL 305 (March 24, 1995)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (March 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (December 17, 1991)
  • K904988 — PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (March 18, 1991)
  • K872233 — INJECT-EASE (September 4, 1987)
  • K842547 — WET-STOP (October 19, 1984)
  • K833344 — AUTO-LANCET (November 7, 1983)

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