Name: Predicase
Price: 199 USD

K-number	K223246
Device name	Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Applicant	Baxter Healthcare Corproration
Product code	BZQ
Device class	Class II
Decision date	Nov 18, 2022
Decision	Substantially Equivalent
Regulation	868.2375

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

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