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FDA 510(k)

SunTech CT40 Spot-check Vital Signs Device

K-Number: K160439 · 2016-07-06

ApplicantSuntech Medical
Decision Date2016-07-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SunTech CT40 Spot-check Vital Signs Device is a medical device manufactured by Suntech Medical. It received FDA 510(k) clearance on 2016-07-06 under approval number K160439. 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 SunTech CT40 Spot-check Vital Signs Device?

SunTech CT40 Spot-check Vital Signs Device is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Suntech Medical. The 510(k) number is K160439.

When was SunTech CT40 Spot-check Vital Signs Device approved by the FDA?

SunTech CT40 Spot-check Vital Signs Device received FDA 510(k) clearance on 2016-07-06, under approval number K160439.

What company makes SunTech CT40 Spot-check Vital Signs Device?

SunTech CT40 Spot-check Vital Signs Device is manufactured by Suntech Medical.

What is the FDA product code for SunTech CT40 Spot-check Vital Signs Device?

The FDA product code for SunTech CT40 Spot-check Vital Signs Device is DXN.

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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

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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