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510(k) K770665

VALVE, PRESSURE, DEMAND by Mcgaw Respiratory Therapy — Product Code CBD

K770665 is an FDA 510(k) premarket notification submitted by Mcgaw Respiratory Therapy for the device "VALVE, PRESSURE, DEMAND". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code CBD (Bottle, Collection, Breathing System (Calibrated)), a Class II device regulated under 21 CFR 880.6740. Mcgaw Respiratory Therapy has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
April 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Breathing System (Calibrated)
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Mcgaw Respiratory Therapy

  • K771550 — MRT DISPENSOR (September 20, 1977)
  • K771516 — CAPILLARY SAMPLE LINE (August 16, 1977)
  • K770286 — VENTILATOR BREATHING CIRCUIT (February 25, 1977)
  • K761300 — NEBULIZER CONTROL UNIT (December 30, 1976)
  • K761298 — PRE-FILLED DISPOSABLE NEBULIZER (December 30, 1976)
  • K761299 — DISPOSABLE NEBULIZER (December 30, 1976)
  • K760998 — ENDOTRACHAEL TUBE AND HOLDER (November 19, 1976)

Other clearances for product code CBD

  • K780340 — IMV SYSTEM (November 27, 1978)
  • K770369 — VACON TM (March 1, 1977)

FDA data resources