Name: Predicase
Price: 199 USD

K-number	K240319
Device name	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
Applicant	Pro Med Instruments GmbH
Product code	HBL
Device class	Class II
Decision date	Apr 24, 2024
Decision	Substantially Equivalent
Regulation	882.4460

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 →

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

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