Product code CCE— Anesthesiology
ARTERIAL BLOOD GAS INTERPRETATION PROG
- Classification name
- Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class 2
- Regulation
- 21 CFR 868.1200
- Advisory panel
- Anesthesiology
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code CCE
FDA has cleared devices under product code CCE between 1976 and 1996, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 1996
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1981
- 1978
- 1977
- 1976
Top applicants under product code CCE
Recent clearances under product code CCE
- K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
- K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
- K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE
- K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
- K896311 — OPTEX BLOOD GAS MONITORING SYSTEM
- K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II
- K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
- K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
- K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
- K875225 — UMBILICAL ARTERY OXYGEN SENSOR
- K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
- K872125 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
- K860808 — CONTINUCATH
- K860106 — OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
- K853786 — OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
- K843912 — INTRAVASCULAR BLOOD GAS SYSTEM
- K840102 — ARTERIAL BLOOD GAS INTERPRETATION PROG
- K832793 — NEOCATH 1000 W/HEPCOTE
- K811071 — VENOUS OXYGEN PROBE
- K781271 — MONITOR, PO2, INTRAVASCULAR
- K780850 — SEARLE NEONATAL OXYGEN PROBE
- K771116 — CATHETER, PO2, INTRAVASUCLAR, CITADEL
- K760350 — MONITOR, CITADEL INTRAVASCULAR PO2
Data sourced from openFDA. This site is unofficial and independent of the FDA.