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510(k) K761294

RESPIRATORY BLOWER by Harris-Lake, Inc. — Product Code BTI

K761294 is an FDA 510(k) premarket notification submitted by Harris-Lake, Inc. for the device "RESPIRATORY BLOWER". The FDA issued a decision of Substantially Equivalent on January 3, 1977. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Harris-Lake, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1977
Date Received
December 21, 1976
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 Harris-Lake, Inc.

  • K761293 — RESPIRATORY HUMIDIFIER (January 3, 1977)
  • K761295 — RESP. AIR TEMP. CONTROL & HAZARD MON. (December 30, 1976)
  • K760333 — JAR, COLLECTOR FOR SUCTION SYSTEMS (October 27, 1976)
  • K760316 — REGULATORS, LOW SUCTION (August 4, 1976)
  • K760317 — REGULATORS, HIGH SUCTION (August 4, 1976)
  • K760314 — FLOWMETER, OXYGEN (August 4, 1976)

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