510(k) K963698
- Device
- CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
- Applicant
- INTERNATIONAL BIOPHYSICS CORP.
- 510(k) number
- K963698
- Product code
- DTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-20
- Date received
- 1996-09-16
- Regulation
- 870.4410
- Classification name
- Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- H. DAVID SHOCKLEY, JR.
- Address
- 4020 S. Industrial Dr. Suite 160 Austin TX US 78744 78744
FDA Registration Numbers#
- 2184009
- 1828100
- 2011171
- 1928237
- 1422634
Source Documents#
Other 510(k) Records For Product Code DTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093650 | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | Medtronic, Inc. | 2010-02-17 |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Medtronic Bio-Medicus, Inc. | 1996-01-16 |
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 3M Health Care, Ltd. | 1990-11-05 |
| K900860 | PERFUSION MONITOR | Cardio Metrics, Inc. | 1990-08-14 |
| K864703 | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | Cardiovascular Devices, Inc. | 1987-02-19 |
| K840749 | GAST STAT MONITORING SYSTEM | Cardiovascular Devices, Inc. | 1984-04-17 |
| K822000 | EXTRACORPOREAL BLOOD GAS SYSTEM | Cardiovascular Devices, Inc. | 1982-12-22 |
Legacy Summary#
summary
FDA Review#
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