K993205 is an FDA 510(k) clearance for the BOOKER BOX, MODEL PAD 5010. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Tz Medical, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on July 20, 2000, 300 days after receiving the submission on September 24, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K993205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1999 |
| Decision Date | July 20, 2000 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | LDD — Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |