DYSIS
FDA 510(k) clearance K092433 · decided 2011-03-10
Clearance details
- K-number
- K092433
- Device name
- DYSIS
- Applicant
- Forth Photonics Hellas SA
- Decision
- Substantially Equivalent
- Date received
- 2009-08-07
- Decision date
- 2011-03-10
- Days to decision
- 580 days
- Clearance type
- Traditional
- Product code
- HEX
- Device class
- 2
- Regulation number
- 884.1630
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Canton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.