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Avant Digital Pulse Oximetry System, Models 4000, 4001

by Nonin Medical, Inc. 510(k)

Active United States

510(k) K041156

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041156 Date9 Jun 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1457-05 FDA Unclassified (pre-2012) initiated 29 Jul 2005 on shared 510(k) K041156

    The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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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