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510(k) K812765

DATASCRIBE #DS-40 by Timeter Instrument Corp. — Product Code BXW

K812765 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "DATASCRIBE #DS-40". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code BXW (Calibrator, Volume, Gas), a Class I device regulated under 21 CFR 868.1870. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
October 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Volume, Gas
Device Class
Class I
Regulation Number
868.1870
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)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • 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)

Other clearances for product code BXW

  • K853848 — RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (December 5, 1985)
  • K831758 — FLOW-CALIBRATION MODULE (July 19, 1983)
  • K830898 — SYRINGE 500BC BE #7000 (May 16, 1983)
  • K810290 — OHIO CAL-CHEK (February 12, 1981)
  • K760520 — CALIPERS, MCGAW SKINFOLD (November 12, 1976)

FDA data resources