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FDA 510(k)

SIEMENS SIRECUST 404N NEONATAL MONITOR

K-Number: K844187 · 1985-04-11

Decision Date1985-04-11
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS SIRECUST 404N NEONATAL MONITOR 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 1985-04-11 under 510(k) number K844187. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SIRECUST 404N NEONATAL MONITOR?

SIEMENS SIRECUST 404N NEONATAL MONITOR is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K844187.

When did SIEMENS SIRECUST 404N NEONATAL MONITOR receive FDA 510(k) clearance?

SIEMENS SIRECUST 404N NEONATAL MONITOR received FDA 510(k) clearance on 1985-04-11, under 510(k) number K844187.

Who is the listed applicant for SIEMENS SIRECUST 404N NEONATAL MONITOR?

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 SIEMENS SIRECUST 404N NEONATAL MONITOR?

The FDA product code for SIEMENS SIRECUST 404N NEONATAL MONITOR is DRT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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