Name: Predicase
Price: 199 USD

K-number	K162582
Device name	HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
Applicant	Fisher & Paykel Healthcare
Product code	HIF
Device class	Class II
Decision date	Jun 23, 2017
Decision	Substantially Equivalent
Regulation	884.1730

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 →

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

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