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FDA 510(k)

BOOKER BOX, MODEL PAD 5010

K-Number: K993205 · 2000-07-20

ApplicantTz Medical, Inc.
Decision Date2000-07-20
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOOKER BOX, MODEL PAD 5010 is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 2000-07-20 under 510(k) number K993205. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOOKER BOX, MODEL PAD 5010?

BOOKER BOX, MODEL PAD 5010 is a medical device that received FDA 510(k) clearance on 2000-07-20. The listed applicant is Tz Medical, Inc.. The 510(k) number is K993205.

When did BOOKER BOX, MODEL PAD 5010 receive FDA 510(k) clearance?

BOOKER BOX, MODEL PAD 5010 received FDA 510(k) clearance on 2000-07-20, under 510(k) number K993205.

Who is the listed applicant for BOOKER BOX, MODEL PAD 5010?

The FDA 510(k) record lists Tz Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOOKER BOX, MODEL PAD 5010?

The FDA product code for BOOKER BOX, MODEL PAD 5010 is LDD.

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Other records listing Tz Medical, Inc. as applicant

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Related Devices (Code: LDD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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