VitalScan ANS

Q: When was VitalScan ANS cleared by the FDA?

VitalScan ANS (K191266) received a 510(k) decision of Substantially Equivalent on January 15, 2020, 250 days after the submission was received.

Q: What is the product code of K191266?

The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.

FDA 510(k) K191266 · Medeia, Inc.

Substantially Equivalent

510(k) numberK191266

Submission

Device name: VitalScan ANS
Applicant: Medeia, Inc.
Santa Barbara, CA, US
Received: May 10, 2019
Decision date: January 15, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2780
Specialty: Cardiovascular

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Questions and answers

When was VitalScan ANS cleared by the FDA?

VitalScan ANS (K191266) received a 510(k) decision of Substantially Equivalent on January 15, 2020, 250 days after the submission was received.

What is the product code of K191266?

The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.