CCEClass II

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

21 CFR 868.1200 / Anesthesiology

CCE is the FDA product code for Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a class II device type, regulated under 21 CFR 868.1200. As of 2026-09-10, FDA records hold 23 510(k) clearances under this code, the most recent dated 1996-12-05, and no recalls.

Classification record

Product code: CCE
Device name: Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Regulation: 21 CFR 868.1200
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 23
Ingested recalls: 0

Clearances, product code CCE

By decision year

23 clearances under product code CCE with a decision year between 1976 and 1996, 1988 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code CCE by decision year
Year	Clearances
1976	1
1977	1
1978	2
1981	1
1983	1
1984	1
1985	2
1986	2
1987	1
1988	3
1989	3
1990	1
1991	2
1992	1
1996	1

Applicants with the most clearances

Product code CCE

Applicants holding the most 510(k) clearances under product code CCE
Applicant	Clearances
American Bentley	3
Baxter Healthcare Corporation	2
C.R. Bard Inc	2
Orange Medical Instruments, Inc.	2
Sherwood Medical Industries	2
Shiley, Inc.	2
Cardiovascular Devices, Inc.	1
G.D. Searle and Co.	1
M. D. Software, Inc.	1
GE Healthcare	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CCE.