The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Booker Box, Model Pad 5010.
| Device ID | K993205 |
| 510k Number | K993205 |
| Device Name: | BOOKER BOX, MODEL PAD 5010 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Contact | Byron Kahler |
| Correspondent | Byron Kahler TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-24 |
| Decision Date | 2000-07-20 |