SUNFLOWER WARNER
FDA 510(k) clearance K120937 · decided 2012-07-06
Clearance details
- K-number
- K120937
- Device name
- SUNFLOWER WARNER
- Applicant
- Atom Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-03-28
- Decision date
- 2012-07-06
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.