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 |