The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Echobright.
Device ID | K093662 |
510k Number | K093662 |
Device Name: | ECHOBRIGHT |
Classification | Anesthesia Conduction Kit |
Applicant | LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
Contact | Jeff Kasoff |
Correspondent | Jeff Kasoff LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-25 |
Decision Date | 2010-06-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ECHOBRIGHT 85718719 4324227 Live/Registered |
AVENT, INC. 2012-08-31 |