Pershield CPR Device

by Rabintex Industries, Ltd.

510(k) K940820

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K940820↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK940820	Date25 Sep 1995Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K940820
FDA Product Code: CBP

Device Class: Class II
Regulation: 21 CFR Part 868.5870
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pershield CPR Device is a valve, non-rebreathing device used in anesthesiology. It is a mouth-to-mouth resuscitator designed for use in cardiopulmonary resuscitation.

The device is supplied non-sterile and is intended for single use. It received FDA 510(k) clearance (K940820) on September 25, 1995, and is classified as a Class II medical device under regulation number 868.5870 with product code CBP.