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510(k) K020730

ORION NASAL CPAP SYSTEM by Bird Products Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2002
Date Received
March 6, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Bird Products Corp.

  • K032451 — BIRD TBIRD VELA VENTILATOR (March 17, 2004)
  • K022674 — BIRD AVEA VENTILATOR (November 6, 2002)
  • K013642 — AVEA (May 22, 2002)
  • 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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