The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Blease Sirius Anesthesia System, Models 3000 And 2000.
| Device ID | K041430 |
| 510k Number | K041430 |
| Device Name: | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 |
| Classification | Gas-machine, Anesthesia |
| Applicant | BLEASE MEDICAL EQUIPMENT LTD. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Arthur J Ward |
| Correspondent | Arthur J Ward BLEASE MEDICAL EQUIPMENT LTD. 962 ALLEGRO LN. 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 | 2004-05-28 |
| Decision Date | 2004-10-07 |
| Summary: | summary |