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FDA 510(k)

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200

K-Number: K052055 · 2006-10-26

ApplicantSmisson-Cartledge Biomedical, LLC
Decision Date2006-10-26
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 is the device name listed in this FDA 510(k) record. The listed applicant is Smisson-Cartledge Biomedical, LLC. It received FDA 510(k) clearance on 2006-10-26 under 510(k) number K052055. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200?

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 is a medical device that received FDA 510(k) clearance on 2006-10-26. The listed applicant is Smisson-Cartledge Biomedical, LLC. The 510(k) number is K052055.

When did SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 receive FDA 510(k) clearance?

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 received FDA 510(k) clearance on 2006-10-26, under 510(k) number K052055.

Who is the listed applicant for SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200?

The FDA 510(k) record lists Smisson-Cartledge Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200?

The FDA product code for SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 is LGZ.

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Other records listing Smisson-Cartledge Biomedical, LLC as applicant

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Official Source

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

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