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FDA 510(k)

SIRECUST 425, RESPECTIVELY SIRECUST 430

K-Number: K851637 · 1985-07-12

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1985-07-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIRECUST 425, RESPECTIVELY SIRECUST 430 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 1985-07-12 under 510(k) number K851637. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRECUST 425, RESPECTIVELY SIRECUST 430?

SIRECUST 425, RESPECTIVELY SIRECUST 430 is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K851637.

When did SIRECUST 425, RESPECTIVELY SIRECUST 430 receive FDA 510(k) clearance?

SIRECUST 425, RESPECTIVELY SIRECUST 430 received FDA 510(k) clearance on 1985-07-12, under 510(k) number K851637.

Who is the listed applicant for SIRECUST 425, RESPECTIVELY SIRECUST 430?

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 SIRECUST 425, RESPECTIVELY SIRECUST 430?

The FDA product code for SIRECUST 425, RESPECTIVELY SIRECUST 430 is DQK.

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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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