ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
FDA 510(k) clearance K081738 · decided 2008-09-17
Clearance details
- K-number
- K081738
- Device name
- ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
- Applicant
- Health & Life Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-19
- Decision date
- 2008-09-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Suit C Carmichael, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.