Name: Predicase
Price: 199 USD

K-number	K182839
Device name	Lifetech Cardio Model 8301 Temporary Pacemaker
Applicant	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Product code	DTE
Device class	Class II
Decision date	Feb 28, 2019
Decision	Substantially Equivalent
Regulation	870.3600

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 →

Lifetech Cardio Model 8301 Temporary Pacemaker

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