The following data is part of a premarket notification filed by Respirics, Inc. with the FDA for Md Turbo.
| Device ID | K051284 |
| 510k Number | K051284 |
| Device Name: | MD TURBO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRICS, INC. 1700 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 -4706 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile RESPIRICS, INC. 1700 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 -4706 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-13 |
| Decision Date | 2005-06-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MD TURBO 78790658 3220854 Dead/Cancelled |
ZHEJIANG HISUN PHARMACEUTICAL CO. LTD 2006-01-12 |
![]() MD TURBO 76346936 not registered Dead/Abandoned |
Respirics, Inc. 2001-12-10 |