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FDA 510(k)

IMFAST

K-Number: K982952 · 1999-03-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1999-03-05
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMFAST 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 1999-03-05 under 510(k) number K982952. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMFAST?

IMFAST is a medical device that received FDA 510(k) clearance on 1999-03-05. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K982952.

When did IMFAST receive FDA 510(k) clearance?

IMFAST received FDA 510(k) clearance on 1999-03-05, under 510(k) number K982952.

Who is the listed applicant for IMFAST?

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 IMFAST?

The FDA product code for IMFAST is LHN.

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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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