System Athena-Product Enhancements, Anesthesia
FDA 510(k) K912145 · S & W Medico Teknik
510(k) numberK912145
Submission
- Device name
- System Athena-Product Enhancements, Anesthesia
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- April 9, 1991
- Decision date
- May 5, 1992
- 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 |
| 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 |
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | American Bentley | 02/12/1988SE |
More from American Bentley
| 510(k) | Device | Decision |
|---|---|---|
| K940933 | 9267 SPO2 Athena ModuleDQA · Traditional | 11/29/1995SE |
| K913013 | TCPO2 9260 Module - System AthenaLKD · Traditional | 05/03/1994SE |
| K915633 | Mod. Type 9230 Temp 1 and Temp 2 System AthenaFLL · Traditional | 06/29/1993SE |
| K930134 | 9055 Irca Option for System Athena 9050 NTDPS · Traditional | 04/09/1993SE |
| K923418 | 9293/1 Interface ModuleDQA · Traditional | 02/23/1993SE |
| K911611 | System Athena, ModificationDRT · Traditional | 02/05/1993SE |
| K922314 | Ventilator Interface 9291/4CBK · Traditional | 12/17/1992SE |
| K912815 | Nibp 9225 CombiDXN · Traditional | 10/09/1992SE |
| K912000 | Type Interface 9271/1 Incubator/WarmerFMZ · Traditional | 09/21/1992SE |
| K912183 | Type 9050/NEODPS · Traditional | 06/23/1992SE |
Questions and answers
When was System Athena-Product Enhancements, Anesthesia cleared by the FDA?
System Athena-Product Enhancements, Anesthesia (K912145) received a 510(k) decision of Substantially Equivalent on May 5, 1992, 392 days after the submission was received.
What is the product code of K912145?
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.