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Index/Rooti Labs Ltd.
ALT-007148K163694Green Status

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Rooti Labs Ltd. ยท Manufacturer

All identifiers (2)
Aletia (canonical)ALT-007148
FDA 510(k) ยท US (primary)K163694

Overview

Accountability Tier
Tier 2

Regulatory Registrations

๐ŸŒ
US
FDA
ID: K163694
510k

Lifecycle Signals

Last Automated Sync
Jun 2026
Last Clinical Review
Not reviewed
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