Name: Predicase
Price: 199 USD

K-number	K232015
Device name	ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
Applicant	Atmos Medizintechnik GmbH & Co. KG
Product code	EOB
Device class	Class II
Decision date	Aug 3, 2023
Decision	Substantially Equivalent
Regulation	874.4760

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 →

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

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