WHOOP ECG (electrocardiogram) Feature (1.0)— 510(k) K243236

Substantially Equivalent

Whoop., Inc.

FDA 510(k) clearance K243236 for WHOOP ECG (electrocardiogram) Feature (1.0), Substantially Equivalent on 2025-04-04. Applicant: Whoop., Inc..

Clearance details

Applicant: Whoop., Inc.
Product code: Code QDA
Advisory panel: Cardiovascular
Date received: 2024-10-10
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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