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 |