Easy Breather Model 100

FDA 510(k) K893213 · Progressive Productions , Ltd.

Substantially Equivalent

510(k) numberK893213

Submission

Device name
Easy Breather Model 100
Applicant
Progressive Productions , Ltd.
Mohrsville, PA, US
Received
April 27, 1989
Decision date
August 4, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYT – Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5935
Specialty
Anesthesiology
Life-sustaining
Yes

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K082657RTX RespiratorBYT · Traditional Medivent Limited10/08/2008SE
K072290Pegaso V, Negavent Respirator, Model: DA-3 PlusBYT · Traditional Dima Italia Srl05/29/2008SE
K924341Hayek Oscillator(Tm)BYT · Traditional Respironics, Inc.07/21/1993SE
K910947NEV-10 Negative Pressure VentilatorBYT · Traditional Lifecare Services, Inc.06/03/1991SE
K905530Puritan-Bennett Companion 500 Liquid Oxygen SystemBYT · Traditional Puritan Bennett Corp.03/01/1991SE
K902764Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional J. H. Emerson Co.11/19/1990SE
K903745The Hayek OscillatorBYT · Traditional Flexco Medical Instruments11/09/1990SE
K902300Easy Breather Model 100 AccessoriesBYT · Traditional Progressive Productions , Ltd.07/19/1990SE
K895849Respironics Vacuvest Respiratory Support SystemBYT · Traditional Respironics, Inc.12/22/1989SE
K894649Emerson 33-CR Chest RespiratorBYT · Traditional Emerson Intl. Co.10/13/1989SE

More from Emerson Intl. Co.

510(k)DeviceDecision
K902300Easy Breather Model 100 AccessoriesBYT · Traditional 07/19/1990SE
K823277The Progressive ChairINN · Traditional 12/13/1982SE
K800697Sunhouse Uvb Ultraviolet Light Tanning · Traditional 05/02/1980SE

Questions and answers

When was Easy Breather Model 100 cleared by the FDA?

Easy Breather Model 100 (K893213) received a 510(k) decision of Substantially Equivalent on August 4, 1989, 99 days after the submission was received.

What is the product code of K893213?

The FDA product code is BYT – Ventilator, External Body, Negative Pressure, Adult (Cuirass), a Class II (moderate risk) device regulated under 21 CFR 868.5935.