The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Blease Frontline Genius Range Anaesthesia Machine.
| Device ID | K982137 |
| 510k Number | K982137 |
| Device Name: | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE |
| Classification | Gas-machine, Anesthesia |
| Applicant | BLEASE MEDICAL EQUIPMENT LTD. 12601 RESEARCH PKWY. ATT: FRANCIS X CASEY Orlando, FL 32826 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey BLEASE MEDICAL EQUIPMENT LTD. 12601 RESEARCH PKWY. ATT: FRANCIS X CASEY Orlando, FL 32826 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1999-04-09 |