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510(k) Data Aggregation

K Number

Device Name

Manufacturer

THE SYNAPTIC CORP.

Date Cleared

1997-06-20

(1207 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

SYNAPTIC 3000

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Synaptic 3000". It does not contain information about acceptance criteria, device performance details, study design, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

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