The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Blease 6200 Anaesthesia Ventilator.
Device ID | K982132 |
510k Number | K982132 |
Device Name: | BLEASE 6200 ANAESTHESIA VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
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 | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-17 |
Decision Date | 1999-04-15 |