Home / 510(k) Clearances / K943842

510(k) K943842

PULSE OXIMETER MODEL 305 by Palco Laboratories, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
August 5, 1994
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)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (March 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (December 17, 1991)
  • K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (June 10, 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)

Other clearances for product code DQA

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • 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)