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510(k) K771516

CAPILLARY SAMPLE LINE by Mcgaw Respiratory Therapy — Product Code CCI

K771516 is an FDA 510(k) premarket notification submitted by Mcgaw Respiratory Therapy for the device "CAPILLARY SAMPLE LINE". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code CCI (Analyzer, Gas, Nitrogen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1690. Mcgaw Respiratory Therapy has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
August 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Nitrogen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1690
Review Panel
AN
Submission Type

Other clearances by Mcgaw Respiratory Therapy

  • K771550 — MRT DISPENSOR (September 20, 1977)
  • K770665 — VALVE, PRESSURE, DEMAND (April 15, 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 CCI

  • K872024 — CO2/02 MONITOR MULTINEX (March 31, 1988)

FDA data resources