Name: Predicase
Price: 199 USD

K-number	K090296
Device name	ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
Applicant	Biodex Medical Systems, Inc.
Product code	KPT
Device class	Class II
Decision date	Feb 19, 2009
Decision	Substantially Equivalent
Regulation	892.1360

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 →

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

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