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Found 2 results

510(k) Data Aggregation

K Number

Device Name

PERCUPUMP II WITH EDA

Manufacturer

Date Cleared

1998-01-27

(47 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PERCUPUMP II WITH EDA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The device is indicated for the administration of ionic and nonionic compounds in conjunction with computed tomography scanning of the body.

The extravasation detecting electrode patch element of the device is indicated for contact with intact skin and single use only.

Device Description

PercuPump II with EDA (Extravasation Detection Accessory)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (PercuPump II with EDA) and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is solely administrative communication regarding regulatory clearance.

Therefore, I cannot extract the requested information from the provided input.

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K Number

Device Name

PERCUPUMP II WITH EDA

Manufacturer

Date Cleared

1997-01-23

(255 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PERCUPUMP II WITH EDA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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