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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

Manufacturer

APEX MEDICAL CORP.

Date Cleared

1997-04-29

(84 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K031546,K071624

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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