510(k) K082657
- Device
- RTX RESPIRATOR
- Applicant
- MEDIVENT LIMITED
- 510(k) number
- K082657
- Product code
- BYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-08
- Date received
- 2008-09-12
- Regulation
- 868.5935
- Classification name
- Ventilator, External Body, Negative Pressure, Adult (cuirass)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SHAHAR HAYEK
- Address
- Maryland House, 10 The Downage London, England GB NW4 1AA NW4 1AA
FDA Registration Numbers#
- 2518422
- 3000126629
- 3023272766
- 3008808130
- 3018783526
- 3007123976
Source Documents#
Other 510(k) Records For Product Code BYT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072290 | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | Dima Italia Srl | 2008-05-29 |
| K924341 | HAYEK OSCILLATOR(TM) | Respironics, Inc. | 1993-07-21 |
| K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR | Lifecare Services, Inc. | 1991-06-03 |
| K905530 | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1991-03-01 |
| K902764 | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | J. H. Emerson Co. | 1990-11-19 |
| K903745 | THE HAYEK OSCILLATOR | Flexco Medical Instruments | 1990-11-09 |
| K902300 | EASY BREATHER MODEL 100 ACCESSORIES | Progressive Productions , Ltd. | 1990-07-19 |
| K895849 | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM | Respironics, Inc. | 1989-12-22 |
| K894649 | EMERSON 33-CR CHEST RESPIRATOR | Emerson Intl. Co. | 1989-10-13 |
| K893213 | EASY BREATHER MODEL 100 | Progressive Productions , Ltd. | 1989-08-04 |
| K881808 | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | J. H. Emerson Co. | 1988-08-04 |
| K881689 | LINDLEY II RESUSCITATOR | Lindley Resuscitator, Inc. | 1988-07-08 |
| K863300 | Q101 DIAGNOSTIC SPIROMETER | Quinton, Inc. | 1986-11-13 |
| K860692 | PTR MK II VENTILATOR | Bear Medical Systems, Inc. | 1986-05-21 |
| K840885 | LAKEVILLE BODY VENTILATOR | Edwards Ventilator Co. | 1984-07-12 |
Legacy Summary#
summary
FDA Review#
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