Name: Predicase
Price: 199 USD

K-number	K100046
Device name	M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
Applicant	Guangdong Biolight Meditech Co., Ltd.
Product code	MHX
Device class	Class II
Decision date	Apr 8, 2010
Decision	Substantially Equivalent
Regulation	870.1025

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 →

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000

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