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FDA 510(k)

XPLAN 2.2 WITH THE BODY SYSTEM

K-Number: K013661 · 2001-12-03

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2001-12-03
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLAN 2.2 WITH THE BODY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K013661. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPLAN 2.2 WITH THE BODY SYSTEM?

XPLAN 2.2 WITH THE BODY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K013661.

When did XPLAN 2.2 WITH THE BODY SYSTEM receive FDA 510(k) clearance?

XPLAN 2.2 WITH THE BODY SYSTEM received FDA 510(k) clearance on 2001-12-03, under 510(k) number K013661.

Who is the listed applicant for XPLAN 2.2 WITH THE BODY SYSTEM?

The FDA 510(k) record lists Radionics, A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPLAN 2.2 WITH THE BODY SYSTEM?

The FDA product code for XPLAN 2.2 WITH THE BODY SYSTEM is MUJ.

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Other records listing Radionics, A Division of Tyco Healthcare Group LP as applicant

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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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