BOOKER BOX, MODEL PAD 5010
FDA 510(k) clearance K993205 · decided 2000-07-20
Clearance details
- K-number
- K993205
- Device name
- BOOKER BOX, MODEL PAD 5010
- Applicant
- Tz Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-24
- Decision date
- 2000-07-20
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005) | Tz Medical, Inc. | 2024-01-09 |