FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
EmbryoScope+
K Number: K173264
·
Decision May 11, 2018
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
44
Applicant Total
3
Review Days
212
Basic Information
- Device Name
- EmbryoScope+
- K Number
- K173264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitrolife A/S
- Date Received
- October 11, 2017
- Decision Date
- May 11, 2018
- 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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