Name: Predicase
Price: 199 USD

K-number	K081506
Device name	HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
Applicant	Hyperbaric America, LLC
Product code	CBF
Device class	Class II
Decision date	Jul 25, 2008
Decision	Substantially Equivalent
Regulation	868.5470

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 →

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS

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