K811638 is an FDA 510(k) clearance for the DATASCOPE INTERNAL DEFIBRILLATOR PADDLES. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 30 days after receiving the submission on June 10, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K811638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 30 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 |