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FDA 510(k)

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535

K-Number: K192092 · 2020-01-23

ApplicantSeca GmbH & Co. KG
Decision Date2020-01-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is a medical device manufactured by Seca GmbH & Co. KG. It received FDA 510(k) clearance on 2020-01-23 under approval number K192092. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Seca GmbH & Co. KG. The 510(k) number is K192092.

When was Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 approved by the FDA?

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 received FDA 510(k) clearance on 2020-01-23, under approval number K192092.

What company makes Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is manufactured by Seca GmbH & Co. KG.

What is the FDA product code for Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

The FDA product code for Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40293498 Bridging the gap: a paradigm shift in medical device regulations in India. Naunyn-Schmiedeberg's archives of pharmacology (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

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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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