The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Modification To Blease Frontline Genius Range, Anesthesia Machines.
| Device ID | K001727 |
| 510k Number | K001727 |
| Device Name: | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES |
| Classification | Gas-machine, Anesthesia |
| Applicant | BLEASE MEDICAL EQUIPMENT LTD. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art 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 | 2000-06-06 |
| Decision Date | 2000-08-09 |