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Bird Tbird Vela Ventilator

by Bird Products Corp. 510(k)

Active United States

510(k) K032451

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032451 Date17 Mar 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  • Withdrawn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-0638-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007

    The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.

Specification

510(k)

510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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