Portable (Ultrasonic) Nebulizer
FDA 510(k) clearance K230379 · decided 2023-11-27
Clearance details
- K-number
- K230379
- Device name
- Portable (Ultrasonic) Nebulizer
- Applicant
- Dongguan Simzo Electronic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-13
- Decision date
- 2023-11-27
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dongguan City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.