The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Echobright.
| Device ID | K111355 |
| 510k Number | K111355 |
| Device Name: | ECHOBRIGHT |
| Classification | Anesthesia Conduction Kit |
| Applicant | LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Contact | Skip Rimer |
| Correspondent | Skip Rimer LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494391994 | K111355 | 000 |
| 10193494392342 | K111355 | 000 |
| 10193494392359 | K111355 | 000 |
| 10193494449183 | K111355 | 000 |
| 10193494449190 | K111355 | 000 |
| 10193494449206 | K111355 | 000 |
| 10193494449213 | K111355 | 000 |
| 10193494449220 | K111355 | 000 |
| 10193494449237 | K111355 | 000 |
| 10193494392281 | K111355 | 000 |
| 10193494392267 | K111355 | 000 |
| 10193494392014 | K111355 | 000 |
| 10193494392045 | K111355 | 000 |
| 10193494392052 | K111355 | 000 |
| 10193494392076 | K111355 | 000 |
| 10193494392083 | K111355 | 000 |
| 10193494392106 | K111355 | 000 |
| 10193494392243 | K111355 | 000 |
| 10193494392250 | K111355 | 000 |
| 10193494452428 | K111355 | 000 |
| 10193494472594 | K111355 | 000 |
| 10193494472600 | K111355 | 000 |
| 30680651392283 | K111355 | 000 |
| 30680651434075 | K111355 | 000 |
| 30680651449185 | K111355 | 000 |
| 30680651449192 | K111355 | 000 |
| 30680651449208 | K111355 | 000 |
| 30680651449215 | K111355 | 000 |
| 30680651449222 | K111355 | 000 |
| 30680651449239 | K111355 | 000 |
| 30680651392269 | K111355 | 000 |
| 30680651392108 | K111355 | 000 |
| 10193494472624 | K111355 | 000 |
| 10193494472648 | K111355 | 000 |
| 10193494472662 | K111355 | 000 |
| 10193494472693 | K111355 | 000 |
| 30680651391996 | K111355 | 000 |
| 30680651392016 | K111355 | 000 |
| 30680651392054 | K111355 | 000 |
| 30680651392085 | K111355 | 000 |
| 30680651452420 | K111355 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ECHOBRIGHT 85718719 4324227 Live/Registered |
AVENT, INC. 2012-08-31 |