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Booker Box, Model Pad 5010

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993205

by Tz Medical, Inc.

Identifiers

510(k) Number
K993205 FDA 510(k)
FDA Product Code
LDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5300 FDA 510(k)
Regulation Number
870.5300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Booker Box, Model Pad 5010 is a Class II cardiac event recorder manufactured by Tz Medical, Inc. It is a multi-port connector with switching capabilities for connection to defibrillators, EP study equipment, and RF electrosurgical generators. The device provides a stable, focal location for multiple wires, cables, and connections.

The Booker Box, Model Pad 5010 is supplied as a reusable device and is not specified as MRI safe. It is authorized under FDA 510(k) clearance with product code LDD and is intended for use in cardiovascular settings. The device is stored at the manufacturer's facility in Lake Oswego, OR.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BOOKER BOX, MODEL PAD 5010 (K993205) — FDA 510(k) | Innolitics, Booker Box - TZ Medical, Tz Booker Box, Pad 5010 - allmed.wiki, Booker Box, Model Pad 5010 510 (k) FDA Premarket Notification K993205 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tz Medical, Inc.

Sources (1)

  • FDA 510(k) K993205 24 fields · synced Oct 6, 2026