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510(k) K894831

PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 by Equi-Tron Mfg., Inc. — Product Code BTI

K894831 is an FDA 510(k) premarket notification submitted by Equi-Tron Mfg., Inc. for the device "PORTABLE AIR COMPRESSOR MODEL NUMBER 8125". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Equi-Tron Mfg., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 31, 1989
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

Other clearances by Equi-Tron Mfg., Inc.

  • K962763 — 2000 MODULAR THIRTY-NINE (October 7, 1996)
  • K903904 — SERIES 2000 ADJUSTABLE BED (October 12, 1990)
  • K903905 — SERIES 9000 LIFT-RECLINE CHAIR (September 17, 1990)
  • K902089 — EQUI-GUARD (ASPIRATOR FILTER) (July 6, 1990)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • 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