K830639 is an FDA 510(k) clearance for the HI FLEX D-700 MODULAR BUBBLE OXYGENA-. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 85 days after receiving the submission on March 1, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K830639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1983 |
| Decision Date | May 25, 1983 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |