Indwelling Blood Carbondioxide Partial Pres. Analy
FDA 510(k) K870911 · American Bentley
510(k) numberK870911
Submission
- Device name
- Indwelling Blood Carbondioxide Partial Pres. Analy
- Applicant
- American Bentley
Irvine, CA, US - Received
- March 6, 1987
- Decision date
- May 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1150
- Specialty
- Anesthesiology
Other 510(k)s with product code CCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071165 | Iscalert Sensor SystemCCC · Traditional | Alertis Medical AS | 11/07/2007SE |
| K983198 | Trendcare Calibrator Model Scu 7007CCC · Traditional | Diametrics Medical, Ltd. | 11/23/1999SE |
| K972314 | Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and…CCC · Traditional | Diametrics Medical, Ltd. | 12/19/1997SE |
| K953893 | Paratrend 7 Intravascular Blood Gas Monitoring SystemCCC · Traditional | Biomedical Sensors, Inc. | 11/04/1997SE |
| K961790 | Point-Of-Care Blood Gas Monitor SystemCCC · Traditional | Optical Sensors, Inc. | 04/09/1997SE |
| K963935 | Olympus Critical Care Monitoring SystemCCC · Traditional | Optical Sensors, Inc. | 01/23/1997SE |
| K951094 | Point-Of-Care Arterial Blood Gas Monitoring SystemCCC · Traditional | Optical Sensors, Inc. | 01/16/1996SE |
| K940188 | Paratrend 7 Satellite Intravascular Blood Gas Monitoring SystemCCC · Traditional | Biomedical Sensors, Ltd. | 11/13/1995SE |
| K931185 | Sensicath Point-Of-Care Blood Gas Monitoring SysteCCC · Traditional | Optical Sensors, Inc. | 10/21/1993SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | Shiley, Inc. | 01/14/1991SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | 02/12/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 11/06/1987SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | 09/01/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | 09/01/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | 08/24/1987SE |
| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
| K862549 | Arterial Blood Filter Holder Model No. Af-HeKRI · Traditional | 07/15/1986SE |
| K860673 | Oxygenator Model Nos. BENTLEY-10A & BENTLEY-10BDTZ · Traditional | 06/26/1986SE |
Questions and answers
When was Indwelling Blood Carbondioxide Partial Pres. Analy cleared by the FDA?
Indwelling Blood Carbondioxide Partial Pres. Analy (K870911) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 84 days after the submission was received.
What is the product code of K870911?
The FDA product code is CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1150.