RTX RESPIRATOR
FDA 510(k) clearance K082657 · decided 2008-10-08
Clearance details
- K-number
- K082657
- Device name
- RTX RESPIRATOR
- Applicant
- Medivent Limited
- Decision
- Substantially Equivalent
- Date received
- 2008-09-12
- Decision date
- 2008-10-08
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- BYT
- Device class
- 2
- Regulation number
- 868.5935
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- London, England, GB
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (K072290) | Dima Italia Srl | 2008-05-29 |
| HAYEK OSCILLATOR(TM) (K924341) | Respironics, Inc. | 1993-07-21 |
| NEV-10 NEGATIVE PRESSURE VENTILATOR (K910947) | Lifecare Services, Inc. | 1991-06-03 |
| PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (K905530) | Puritan Bennett Corp. | 1991-03-01 |
| EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (K902764) | J. H. Emerson Co. | 1990-11-19 |
| THE HAYEK OSCILLATOR (K903745) | Flexco Medical Instruments | 1990-11-09 |
| EASY BREATHER MODEL 100 ACCESSORIES (K902300) | Progressive Productions , Ltd. | 1990-07-19 |
| RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (K895849) | Respironics, Inc. | 1989-12-22 |
| EMERSON 33-CR CHEST RESPIRATOR (K894649) | Emerson Intl. Co. | 1989-10-13 |
| EASY BREATHER MODEL 100 (K893213) | Progressive Productions , Ltd. | 1989-08-04 |
| EMERSON CHEST RESPIRATOR, MODEL 33-CRE (K881808) | J. H. Emerson Co. | 1988-08-04 |
| LINDLEY II RESUSCITATOR (K881689) | Lindley Resuscitator, Inc. | 1988-07-08 |
Recalls involving this device
No recalls on record reference this clearance.