Name: Predicase
Price: 199 USD

K-number	K251663
Device name	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
Applicant	Datex-Ohmeda, Inc.
Product code	FMZ
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	880.5400

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

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