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Smartmonitor 2, Model 4000

by Respironics Georgia, Inc. 510(k)

Active United States

510(k) K011597

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK011597 Date11 Jan 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-1411-2009 FDA Unclassified (pre-2012) initiated 23 Apr 2009

    Audible alarm failure.

    • Terminated Z-1093-2008 FDA Unclassified (pre-2012) initiated 15 Oct 2007

    Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Specification

510(k)

510(k) Number
FDA Product Code
FLS
Device Class
Class II
Regulation
21 CFR Part 868.2377
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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