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FDA 510(k)

VitalScan ANS

K-Number: K191266 · 2020-01-15

ApplicantMedeia, Inc.
Decision Date2020-01-15
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalScan ANS is the device name listed in this FDA 510(k) record. The listed applicant is Medeia, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K191266. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalScan ANS?

VitalScan ANS is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Medeia, Inc.. The 510(k) number is K191266.

When did VitalScan ANS receive FDA 510(k) clearance?

VitalScan ANS received FDA 510(k) clearance on 2020-01-15, under 510(k) number K191266.

Who is the listed applicant for VitalScan ANS?

The FDA 510(k) record lists Medeia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalScan ANS?

The FDA product code for VitalScan ANS is JOM.

Other records listing Medeia, 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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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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