ECG analysis platform

FDA REGULATORY CONTENT PLACEHOLDER. US labeling PLACEHOLDER - Rx-only decision, wording and eIFU pending approval. Not approved for clinical use.

Cardiovolt ECG analysis

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Device label

Medical device

Cardiovolt AIRE

Manufacturer

Cardiovolt.ai Ltd
86-90 Paul Street
London EC2A 4NE
United Kingdom

US representative

PLACEHOLDER: Approved representative details pending.

Software identification

Version 0.0.1-US
Release date Not Approved

Instructions for Use

Consult Electronic Instructions for Use (IFU) https://ifu.example.invalid

US eIFU - PLACEHOLDER

Consult IFU for symbols glossary.

A paper IFU can be requested by emailing: support@cardiovolt.ai

A paper IFU will be made available at no additional cost within 7 days.

Unique Device Identification
PLACEHOLDER: (01)5070004854201(11)Not Approved(8012)0.0.1-US

Conformity marking

PLACEHOLDER: US regulatory marking details pending.