Cdi (TM) System 100 Monitoring System
FDA 510(k) K902654 · 3M Health Care, Ltd.
510(k) numberK902654
Submission
- Device name
- Cdi (TM) System 100 Monitoring System
- Applicant
- 3M Health Care, Ltd.
Irvine, CA, US - Received
- June 15, 1990
- Decision date
- November 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTY – Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4410
- Specialty
- Cardiovascular
Other 510(k)s with product code DTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093650 | Biotrend Oxygen Saturation and Hematocrit SystemDTY · Traditional | Medtronic, Inc. | 02/17/2010SE |
| K963698 | CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4DTY · Traditional | International Biophysics Corp. | 03/20/1997SE |
| K954501 | Biotrend Oxygen Saturation & Hematocrit SystemDTY · Traditional | Medtronic Bio-Medicus, Inc. | 01/16/1996SE |
| K900860 | Perfusion MonitorDTY · Traditional | Cardio Metrics, Inc. | 08/14/1990SE |
| K864703 | Modified Gas-Stat(Tm) Monitoring SystemDTY · Traditional | Cardiovascular Devices, Inc. | 02/19/1987SE |
| K840749 | Gast Stat Monitoring SystemDTY · Traditional | Cardiovascular Devices, Inc. | 04/17/1984SE |
| K822000 | Extracorporeal Blood Gas SystemDTY · Traditional | Cardiovascular Devices, Inc. | 12/22/1982SE |
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| K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioDRY · Traditional | 11/10/1993SE |
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Questions and answers
When was Cdi (TM) System 100 Monitoring System cleared by the FDA?
Cdi (TM) System 100 Monitoring System (K902654) received a 510(k) decision of Substantially Equivalent on November 5, 1990, 143 days after the submission was received.
What is the product code of K902654?
The FDA product code is DTY – Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4410.