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Found 1 results

510(k) Data Aggregation

K Number

Device Name

A Breathing System (ABS)

Manufacturer

DeepWell DTx Inc.

Date Cleared

2024-08-01

(268 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

DeepWell DTx Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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