FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
K Number: K232493
·
Decision May 7, 2024
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
44
Applicant Total
1
Review Days
264
Basic Information
- Device Name
- Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K Number
- K232493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wuhan Huchuang Union Technology Co., Ltd.
- Date Received
- August 17, 2023
- Decision Date
- May 7, 2024
- 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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