FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
EMBRYOSCOPE AND EMBRYOSLIDE
K Number: K092183
·
Decision Jan 11, 2011
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
45
Applicant Total
4
Review Days
539
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Basic Information
- Device Name
- EMBRYOSCOPE AND EMBRYOSLIDE
- K Number
- K092183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unisense Fertilitech A/S
- Date Received
- July 21, 2009
- Decision Date
- January 11, 2011
- Product Code
- MQG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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