Name: Predicase
Price: 199 USD

K-number	K103523
Device name	185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Applicant	International Biomedical, Ltd.
Product code	FPL
Device class	Class II
Decision date	May 11, 2011
Decision	Substantially Equivalent
Regulation	880.5410

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Source

View the full FDA submission: accessdata.fda.gov

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185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

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