ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
FDA 510(k) clearance K083256 · decided 2009-06-26
Clearance details
- K-number
- K083256
- Device name
- ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
- Applicant
- K-Jump Health Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-04
- Decision date
- 2009-06-26
- Days to decision
- 234 days
- Clearance type
- Abbreviated
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch K-Jump Health Co.
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
No recalls on record reference this clearance.