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510(k) K952616

MICROTIME by Westmed Intl. — Product Code BTI

K952616 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "MICROTIME". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Westmed Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
June 6, 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

Other clearances by Westmed Intl.

  • K955047 — WESTMED CIRCULARIE PEP DEVICES (March 27, 1996)
  • K954271 — WESTMED CONDESATE COLLECTION TRAP (December 28, 1995)
  • K953687 — WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (September 18, 1995)
  • K953506 — WESTMED RESPIRATORY LUER ADAPTOR (September 15, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K924944 — INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (July 2, 1993)
  • K925173 — BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (January 15, 1993)

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