Stockert-Shiley Universal Level Sensor
FDA 510(k) K843802 · Shiley, Inc.
510(k) numberK843802
Submission
- Device name
- Stockert-Shiley Universal Level Sensor
- Applicant
- Shiley, Inc.
Mchenry, IL, US - Received
- September 27, 1984
- Decision date
- December 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4340
- Specialty
- Cardiovascular
Other 510(k)s with product code DTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150530 | Level Sensor, Level Sensor TapeDTW · Special | Medtronic, Inc. | 05/08/2015SE |
| K041558 | Stockertir Purge Control (Apc) SystemDTW · Special | Stockert Instrumente GmbH | 07/02/2004SE |
| K992857 | Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070DTW · Traditional | Rocky Mountain Research, Inc. | 11/10/1999SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | Stoeckert Instrumente | 02/22/1996SE |
| K910599 | Cardiopulmonary Bypass Level Sensing MonitorDTW · Traditional | Jtl Medical Corp. | 05/20/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/18/1993SE |
| K915337 | Capiox Level AlarmDTW · Traditional | Terumo Medical Corp. | 02/21/1992SE |
| K900910 | Cobe Air Emboli Protection System (Aeps)DTW · Traditional | Cobe Laboratories, Inc. | 05/22/1990SE |
| K900815 | Sarns 9000 Perfusion System W/Alert Only LevelDTW · Traditional | 3M Company | 05/09/1990SE |
| K873206 | Myocardial Temp. Sensor W/Type T ThermocoupleDTW · Traditional | Respiratory Support Products, Inc. | 09/30/1987SE |
More from Respiratory Support Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| 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 |
Questions and answers
When was Stockert-Shiley Universal Level Sensor cleared by the FDA?
Stockert-Shiley Universal Level Sensor (K843802) received a 510(k) decision of Substantially Equivalent on December 27, 1984, 91 days after the submission was received.
What is the product code of K843802?
The FDA product code is DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4340.