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510(k) K951926

ALRECO 40400 by Allan Rehnstrom AB — Product Code BTI

K951926 is an FDA 510(k) premarket notification submitted by Allan Rehnstrom AB for the device "ALRECO 40400". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1995
Date Received
April 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

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  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources