WATCHHALER
FDA 510(k) clearance K080100 · decided 2008-06-30
Clearance details
- K-number
- K080100
- Device name
- WATCHHALER
- Applicant
- Activaero America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-14
- Decision date
- 2008-06-30
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- NVP
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.