K-number	K062342
Device name	TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
Applicant	Sentra Medical Devices, LLC
Product code	DRS
Device class	Class II
Decision date	Sep 25, 2006
Decision	Substantially Equivalent
Regulation	870.2850

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT

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