Biomedical Sensors-Shiley BGM 4000 Intra Blood Gas
FDA 510(k) K901548 · Shiley, Inc.
510(k) numberK901548
Submission
- Device name
- Biomedical Sensors-Shiley BGM 4000 Intra Blood Gas
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- April 3, 1990
- Decision date
- January 14, 1991
- 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
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| 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 |
| K891013 | Medtronic Intravascular Blood Gas MonitoringCCC · Traditional | Medtronic Vascular | 08/02/1989SE |
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| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
| K900548 | Shiley Phonation ValveBTO · Traditional | 04/23/1990SE |
Questions and answers
When was Biomedical Sensors-Shiley BGM 4000 Intra Blood Gas cleared by the FDA?
Biomedical Sensors-Shiley BGM 4000 Intra Blood Gas (K901548) received a 510(k) decision of Substantially Equivalent on January 14, 1991, 286 days after the submission was received.
What is the product code of K901548?
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.