K823828 is an FDA 510(k) clearance for the THERACARD 400. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Siemens Medical Solutions USA, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983, 87 days after receiving the submission on December 20, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K823828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1982 |
| Decision Date | March 17, 1983 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LDD — Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |