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510(k) K935693

AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT by Vortran Medical Technology 1, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
November 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Vortran Medical Technology 1, Inc.

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  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)
  • K073261 — VAR MONITOR (May 23, 2008)
  • K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (July 15, 2004)
  • K003684 — PERCUSSIVENEB, MODEL PN-2001 (February 23, 2001)
  • K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (July 5, 2000)

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  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
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