RAPID-I
FDA 510(k) clearance K090832 · decided 2009-12-23
Clearance details
- K-number
- K090832
- Device name
- RAPID-I
- Applicant
- Vitrolife Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2009-03-26
- Decision date
- 2009-12-23
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Se-400 92 Goteborg, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.