Home / 510(k) Clearances / K761293

510(k) K761293

RESPIRATORY HUMIDIFIER by Harris-Lake, Inc. — Product Code BTT

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
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Harris-Lake, Inc.

  • K761294 — RESPIRATORY BLOWER (January 3, 1977)
  • K761295 — RESP. AIR TEMP. CONTROL & HAZARD MON. (December 30, 1976)
  • K760333 — JAR, COLLECTOR FOR SUCTION SYSTEMS (October 27, 1976)
  • K760314 — FLOWMETER, OXYGEN (August 4, 1976)
  • K760317 — REGULATORS, HIGH SUCTION (August 4, 1976)
  • K760316 — REGULATORS, LOW SUCTION (August 4, 1976)

Other clearances for product code BTT

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)