Name: Predicase
Price: 199 USD

K-number	K010436
Device name	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
Applicant	Remote Diagnostic Technologies , Ltd.
Product code	DXH
Device class	Class II
Decision date	May 14, 2001
Decision	Substantially Equivalent
Regulation	870.2920

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 →

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

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