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Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI

by Konica Minolta Sensing, Inc. 510(k)

Active United States

510(k) K010413

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010413 Date2 Aug 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0289-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0290-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003

    Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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