EMBRYON ULTRASOUND NEEDLE GUIDE
FDA 510(k) clearance K032015 · decided 2003-08-08
Clearance details
- K-number
- K032015
- Device name
- EMBRYON ULTRASOUND NEEDLE GUIDE
- Applicant
- Rocket Medical Plc
- Decision
- Substantially Equivalent
- Date received
- 2003-06-30
- Decision date
- 2003-08-08
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.