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 |