Emerson 33-AN Negative Pressure Respirator Alarm
FDA 510(k) K902764 · J. H. Emerson Co.
510(k) numberK902764
Submission
- Device name
- Emerson 33-AN Negative Pressure Respirator Alarm
- Applicant
- J. H. Emerson Co.
Cambridge, MA, US - Received
- June 25, 1990
- Decision date
- November 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code BYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K082657 | RTX RespiratorBYT · Traditional | Medivent Limited | 10/08/2008SE |
| K072290 | Pegaso V, Negavent Respirator, Model: DA-3 PlusBYT · Traditional | Dima Italia Srl | 05/29/2008SE |
| K924341 | Hayek Oscillator(Tm)BYT · Traditional | Respironics, Inc. | 07/21/1993SE |
| K910947 | NEV-10 Negative Pressure VentilatorBYT · Traditional | Lifecare Services, Inc. | 06/03/1991SE |
| K905530 | Puritan-Bennett Companion 500 Liquid Oxygen SystemBYT · Traditional | Puritan Bennett Corp. | 03/01/1991SE |
| K903745 | The Hayek OscillatorBYT · Traditional | Flexco Medical Instruments | 11/09/1990SE |
| K902300 | Easy Breather Model 100 AccessoriesBYT · Traditional | Progressive Productions , Ltd. | 07/19/1990SE |
| K895849 | Respironics Vacuvest Respiratory Support SystemBYT · Traditional | Respironics, Inc. | 12/22/1989SE |
| K894649 | Emerson 33-CR Chest RespiratorBYT · Traditional | Emerson Intl. Co. | 10/13/1989SE |
| K893213 | Easy Breather Model 100BYT · Traditional | Progressive Productions , Ltd. | 08/04/1989SE |
More from Progressive Productions , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | 01/12/1993SE |
| K924174 | Emerson In-Exsufflator, Models 2-CM & 2-CANHJ · Traditional | 11/17/1992SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864379 | Emerson 3MV Volume VentilatorCBK · Traditional | 12/15/1986SE |
| K864394 | Emerson 3MV Volume Ventilator · Traditional | 12/05/1986SE |
Questions and answers
When was Emerson 33-AN Negative Pressure Respirator Alarm cleared by the FDA?
Emerson 33-AN Negative Pressure Respirator Alarm (K902764) received a 510(k) decision of Substantially Equivalent on November 19, 1990, 147 days after the submission was received.
What is the product code of K902764?
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.