COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
FDA 510(k) clearance K051365 · decided 2005-07-22
Clearance details
- K-number
- K051365
- Device name
- COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
- Applicant
- K-Jump Health Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-25
- Decision date
- 2005-07-22
- Days to decision
- 58 days
- Clearance type
- Abbreviated
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.