BOOKER BOX, MODEL PAD 5010— 510(k) K993205

Substantially Equivalent

Tz Medical, Inc.

FDA 510(k) clearance K993205 for BOOKER BOX, MODEL PAD 5010, Substantially Equivalent on 2000-07-20. Applicant: Tz Medical, Inc..

Clearance details

Applicant: Tz Medical, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1999-09-24
Decision date: 2000-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.