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510(k) K823775

BORDON GAGE REGULATOR #BG by Timeter Instrument Corp. — Product Code CCN

K823775 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "BORDON GAGE REGULATOR #BG". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 14, 1982
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 by Timeter Instrument Corp.

  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K871603 — CRITERION II & IIA OXYGEN CONCENTRATORS (August 13, 1987)
  • K864836 — L.A.P. SPIROMETER (March 6, 1987)
  • K834274 — CRITERION I (April 13, 1984)
  • K822746 — RT-200 CALIBRATION ANALYZER (October 13, 1982)
  • K812766 — PCS-5 ACCESSORIES (December 17, 1981)
  • K813234 — OHIO AIR ADAPTOR (December 8, 1981)
  • K813235 — DISS FEMALE AIR ADAPTOR (December 8, 1981)
  • K812767 — SNIFF AIR COMPRESSOR #SF-6 (November 27, 1981)

Other clearances for product code CCN

  • K934945 — FLOWMETER NIPPLE ADAPTOR (November 17, 1993)
  • 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)
  • K863659 — FLOW INTERRUPTION INDICATOR (October 15, 1986)
  • K863657 — OXYGEN CONSERVATOR (October 15, 1986)
  • K802037 — VITAMIN B12 FOLATE RADIOASSAY (November 21, 1980)

FDA data resources