Home / 510(k) Clearances / K863801

510(k) K863801

TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR by Traverse Medical Monitors — Product Code CBS

K863801 is an FDA 510(k) premarket notification submitted by Traverse Medical Monitors for the device "TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Traverse Medical Monitors has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
September 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type

Other clearances by Traverse Medical Monitors

  • K875268 — TMM MODEL 2500 CAPMONITOR (January 22, 1988)

Other clearances for product code CBS

  • K974903 — GAS MODULE II, MODEL 0998-00-0143 (March 13, 1998)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV (May 3, 1996)
  • K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (August 2, 1995)
  • K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (March 21, 1995)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)
  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (June 17, 1991)
  • K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (February 12, 1990)

FDA data resources