The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 And 690.
| Device ID | K003251 |
| 510k Number | K003251 |
| Device Name: | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2001-05-23 |