CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4
FDA 510(k) K963698 · International Biophysics Corp.
510(k) numberK963698
Submission
- Device name
- CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4
- Applicant
- International Biophysics Corp.
Austin, TX, US - Received
- September 16, 1996
- Decision date
- March 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
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| K954501 | Biotrend Oxygen Saturation & Hematocrit SystemDTY · Traditional | Medtronic Bio-Medicus, Inc. | 01/16/1996SE |
| K902654 | Cdi (TM) System 100 Monitoring SystemDTY · Traditional | 3M Health Care, Ltd. | 11/05/1990SE |
| 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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Questions and answers
When was CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4 cleared by the FDA?
CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4 (K963698) received a 510(k) decision of Substantially Equivalent on March 20, 1997, 185 days after the submission was received.
What is the product code of K963698?
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.