Name: Predicase
Price: 199 USD

K-number	K221321
Device name	MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
Applicant	Ge Medical Systems Information Technologies, Inc.
Product code	DPS
Device class	Class II
Decision date	Oct 18, 2022
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System

Everything you need for a 510(k) submission. Nothing you don't.