Name: Predicase
Price: 199 USD

K-number	K091548
Device name	AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
Applicant	Amco International Manufacturing & Design, Inc.
Product code	MKJ
Device class	Class III
Decision date	Aug 7, 2009
Decision	Substantially Equivalent
Regulation	870.5310

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 →

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A

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