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510(k) K934945

FLOWMETER NIPPLE ADAPTOR by Cardio-Search , Ltd. — Product Code CCN

K934945 is an FDA 510(k) premarket notification submitted by Cardio-Search , Ltd. for the device "FLOWMETER NIPPLE ADAPTOR". The FDA issued a decision of Substantially Equivalent on November 17, 1993. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1993
Date Received
October 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Device Class
Class I
Regulation Number
868.2300
Review Panel
AN
Submission Type

Other clearances for product code CCN

  • K920783 — OXYGEN FLOW CONTROLLER (September 18, 1992)
  • K872038 — NEB-U-VENT (August 10, 1987)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 15, 1986)
  • K863657 — OXYGEN CONSERVATOR (October 15, 1986)
  • K863659 — FLOW INTERRUPTION INDICATOR (October 15, 1986)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • K802037 — VITAMIN B12 FOLATE RADIOASSAY (November 21, 1980)

FDA data resources