FDA 510(k)

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470

K-Number: K990247 · 1999-05-28

ApplicantPolymer Technology Systems, Inc.

Decision Date1999-05-28

Product CodeLBR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K990247. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470?

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K990247.

When did MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 receive FDA 510(k) clearance?

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 received FDA 510(k) clearance on 1999-05-28, under 510(k) number K990247.

Who is the listed applicant for MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470?

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

What is the FDA product code for MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470?

The FDA product code for MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 is LBR.

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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.