FDA Product Code
FDA Product Code DTY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4410
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093650 | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | Medtronic, Inc. | 2010-02-17 | Traditional | PDF ↗ |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | International Biophysics Corp. | 1997-03-20 | Traditional | PDF ↗ |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Medtronic Bio-Medicus, Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 3M Health Care, Ltd. | 1990-11-05 | Traditional | PDF ↗ |
| K900860 | PERFUSION MONITOR | Cardio Metrics, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K864703 | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | Cardiovascular Devices, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K840749 | GAST STAT MONITORING SYSTEM | Cardiovascular Devices, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K822000 | EXTRACORPOREAL BLOOD GAS SYSTEM | Cardiovascular Devices, Inc. | 1982-12-22 | Traditional | PDF ↗ |
Product code DTY · Class II · Cardiovascular. Data: openFDA.