Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer
FDA 510(k) K955152 · Stoeckert Instrumente
510(k) numberK955152
Submission
- Device name
- Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer
- Applicant
- Stoeckert Instrumente
North Attleboro, MA, US - Received
- November 13, 1995
- Decision date
- February 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K860076 | Gambro Ultrasonic Blood Level Detector Uld 10-200DTW · Traditional | Gambro, Inc. | 05/30/1986SE |
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| 510(k) | Device | Decision |
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| K002273 | Stockert A272 Series Pediatric Aortic CannulaeDWF · Abbreviated | 01/29/2001SE |
| K001961 | Stockert A242 and A252 Series Arterial Femoral CannulaeDWF · Abbreviated | 01/25/2001SE |
| K002118 | Stockert Compact System Version 2.0DTQ · Special | 08/09/2000SE |
| K992635 | Interface Module IdddKRI · Special | 12/20/1999SE |
| K990512 | Stockert Power Supply Unit for S3 ComponentsKRI · Traditional | 11/23/1999SE |
| K982014 | Stockert Compact SystemDTQ · Special | 09/04/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | 09/10/1997SE |
| K962320 | S3 Cardioplegia ControlDTR · Traditional | 01/10/1997SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | 02/21/1996SE |
Questions and answers
When was Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer cleared by the FDA?
Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer (K955152) received a 510(k) decision of Substantially Equivalent on February 22, 1996, 101 days after the submission was received.
What is the product code of K955152?
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.