Monitor, Citadel Intravascular PO2
FDA 510(k) K760350 · Sherwood Medical Industries
510(k) numberK760350
Submission
- Device name
- Monitor, Citadel Intravascular PO2
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- August 2, 1976
- Decision date
- October 29, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
Other 510(k)s with product code CCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935778 | Via 1-01 Infusion Pump/Blood Chemistry SystemCCE · Traditional | Via Medical Corp. | 12/05/1996SEKD |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | S & W Medico Teknik | 05/05/1992SE |
| K910453 | Tops Needle Tip Probe & PVC Tip ProbeCCE · Traditional | Baxter Healthcare Corp | 08/13/1991SE |
| K905397 | PB3200 Intra-Arterial Blood Gas Monitoring SystemCCE · Traditional | Puritan Bennett Corp. | 05/14/1991SE |
| K896311 | Optex Blood Gas Monitoring SystemCCE · Traditional | Optex Biomedical | 01/03/1990SE |
| K890624 | Tissue Oxygen Monitor System, Model IICCE · Traditional | Baxter Healthcare Corp | 12/22/1989SE |
| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K884063 | Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional | C.R. Bard, Inc. | 12/16/1988SE |
| K875225 | Umbilical Artery Oxygen SensorCCE · Traditional | Ohmeda Medical | 03/04/1988SE |
More from Ohmeda Medical
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
Questions and answers
When was Monitor, Citadel Intravascular PO2 cleared by the FDA?
Monitor, Citadel Intravascular PO2 (K760350) received a 510(k) decision of Substantially Equivalent on October 29, 1976, 88 days after the submission was received.
What is the product code of K760350?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.