BUZZY
FDA 510(k) clearance K130631 · decided 2014-08-13
Clearance details
- K-number
- K130631
- Device name
- BUZZY
- Applicant
- Mmj Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-03-08
- Decision date
- 2014-08-13
- Days to decision
- 523 days
- Clearance type
- Traditional
- Product code
- PHW
- Device class
- 1
- Regulation number
- 890.5975
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.