Sarns 9000 Perfusion System W/Alert Only Level
FDA 510(k) K900815 · 3M Company
510(k) numberK900815
Submission
- Device name
- Sarns 9000 Perfusion System W/Alert Only Level
- Applicant
- 3M Company
Ann Arbor, MI, US - Received
- February 21, 1990
- Decision date
- May 9, 1990
- 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
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| 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 |
| 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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Questions and answers
When was Sarns 9000 Perfusion System W/Alert Only Level cleared by the FDA?
Sarns 9000 Perfusion System W/Alert Only Level (K900815) received a 510(k) decision of Substantially Equivalent on May 9, 1990, 77 days after the submission was received.
What is the product code of K900815?
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.