Name: Predicase
Price: 199 USD

K-number	K964939
Device name	THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
Applicant	Creative Biomedics, Inc.
Product code	BZC
Device class	Class II
Decision date	Mar 6, 1997
Decision	Substantially Equivalent
Regulation	868.1880

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Source

View the full FDA submission: accessdata.fda.gov

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THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS

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