Name: Predicase
Price: 199 USD

K-number	DEN240031
Device name	Prapela SVS hospital bassinet pad (model P01)
Applicant	Prapela, Inc.
Product code	QVY
Device class	Class II
Decision date	Apr 4, 2025
Decision	Not Substantially Equivalent
Regulation	880.5151

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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Prapela SVS hospital bassinet pad (model P01)

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