BLEASE 6200 ANAESTHESIA VENTILATOR
FDA 510(k) clearance K982132 · decided 1999-04-15
Clearance details
- K-number
- K982132
- Device name
- BLEASE 6200 ANAESTHESIA VENTILATOR
- Applicant
- Blease Medical Equipment , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-17
- Decision date
- 1999-04-15
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Blease Medical Equipment
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South recall (Z-0165-04) | Abbott Laboratories Diagnostic Div | 2004-07-20 |