K-number	K920183
Device name	TECH DYNE - HP-2000, SKREEN TEST, RMS-200
Applicant	Tech Dyne Group
Product code	LBB
Device class	Class II
Decision date	Jun 15, 1992
Decision	Substantially Equivalent
Regulation	888.1240

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 →

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 →

TECH DYNE - HP-2000, SKREEN TEST, RMS-200

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