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FDA 510(k)

The Heart Seat

K-Number: K222330 · 2023-04-24

ApplicantCasana Care, Inc.
Decision Date2023-04-24
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The Heart Seat is the device name listed in this FDA 510(k) record. The listed applicant is Casana Care, Inc.. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K222330. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Heart Seat?

The Heart Seat is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Casana Care, Inc.. The 510(k) number is K222330.

When did The Heart Seat receive FDA 510(k) clearance?

The Heart Seat received FDA 510(k) clearance on 2023-04-24, under 510(k) number K222330.

Who is the listed applicant for The Heart Seat?

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

What is the FDA product code for The Heart Seat?

The FDA product code for The Heart Seat is MWI.

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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