GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
FDA 510(k) clearance K041079 · decided 2004-09-28
Clearance details
- K-number
- K041079
- Device name
- GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
- Applicant
- Guan Hong Enterprise Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-26
- Decision date
- 2004-09-28
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guan Hong Enterprise 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.