The following data is part of a premarket notification filed by Blease Usa, Inc. with the FDA for Bleas Esiriuc Anaesthsia System, Models 3000, 2000.
| Device ID | K051629 |
| 510k Number | K051629 |
| Device Name: | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 |
| Classification | Gas-machine, Anesthesia |
| Applicant | BLEASE USA, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur J Ward |
| Correspondent | Arthur J Ward BLEASE USA, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-09-23 |
| Summary: | summary |