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510(k) K043162

PMP4 OXY PRO by Card Guard Scientific Survival , Ltd. — Product Code DQA

K043162 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "PMP4 OXY PRO". The FDA issued a decision of Substantially Equivalent on December 29, 2004. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2004
Date Received
November 16, 2004
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 Card Guard Scientific Survival , Ltd.

  • K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (August 1, 2011)
  • K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (April 6, 2011)
  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)

Other clearances for product code DQA

  • K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor ( (May 29, 2026)
  • K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, P (May 11, 2026)
  • K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Na (May 1, 2026)
  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (April 14, 2026)
  • 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)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)

FDA data resources