Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense— 510(k) K223246

Name: FDA 510(k) clearance K223246
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Substantially Equivalent

Baxter Healthcare Corproration

FDA 510(k) clearance K223246 for Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense, Substantially Equivalent on 2022-11-18. Applicant: Baxter Healthcare Corproration. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corproration
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2022-10-20
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Batesville, IN, US

Download summary PDF View on FDA.gov ↗

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