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FDA 510(k)

THERACARD 400

K-Number: K823828 · 1983-03-17

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1983-03-17
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERACARD 400 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K823828. 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 THERACARD 400?

THERACARD 400 is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K823828.

When did THERACARD 400 receive FDA 510(k) clearance?

THERACARD 400 received FDA 510(k) clearance on 1983-03-17, under 510(k) number K823828.

Who is the listed applicant for THERACARD 400?

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

What is the FDA product code for THERACARD 400?

The FDA product code for THERACARD 400 is 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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