K-number	K250560
Device name	BEE HA
Applicant	NGMedical GmbH
Product code	ODP
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

BEE HA

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