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 |