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FDA 510(k)

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

K-Number: K050197 · 2006-10-06

ApplicantMinitube of America, Inc.
Decision Date2006-10-06
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 is the device name listed in this FDA 510(k) record. The listed applicant is Minitube of America, Inc.. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K050197. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045?

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Minitube of America, Inc.. The 510(k) number is K050197.

When did MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 receive FDA 510(k) clearance?

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 received FDA 510(k) clearance on 2006-10-06, under 510(k) number K050197.

Who is the listed applicant for MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045?

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

What is the FDA product code for MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045?

The FDA product code for MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 is MQG.

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Other records listing Minitube of America, Inc. as applicant

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Official Source

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