Name: Predicase
Price: 199 USD

K-number	K051370
Device name	STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
Applicant	Baxter Healthcare Corp
Product code	JOL
Device class	Class II
Decision date	Aug 12, 2005
Decision	Substantially Equivalent
Regulation	880.6740

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 →

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

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