Name: Predicase
Price: 199 USD

K-number	K200376
Device name	Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
Applicant	Navbit Pty, Ltd.
Product code	OLO
Device class	Class II
Decision date	Dec 10, 2020
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

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