The following data is part of a premarket notification filed by Medivent Limited with the FDA for Rtx Respirator.
| Device ID | K082657 |
| 510k Number | K082657 |
| Device Name: | RTX RESPIRATOR |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | MEDIVENT LIMITED MARYLAND HOUSE, 10 THE DOWNAGE London, England, GB Nw4 1aa |
| Contact | Shahar Hayek |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060526070005 | K082657 | 000 |
| 05060526070487 | K082657 | 000 |