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510(k) K032451

BIRD TBIRD VELA VENTILATOR by Bird Products Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2004
Date Received
August 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Bird Products Corp.

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  • K020746 — BIRD TBIRD VELA VENTILATOR (April 22, 2002)
  • K003770 — BIRD TBIRD LEGACY VENTILATOR (December 15, 2000)
  • K990856 — HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 (January 11, 2000)
  • K993449 — BIRD V.I.P. GOLD/STERLING (December 20, 1999)
  • K982580 — BIRD MONITOR INTERFACE (October 22, 1998)
  • K981971 — TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WIT (August 24, 1998)
  • K973646 — BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER (May 7, 1998)

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