FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYOTOP
K Number: K112695
·
Decision Dec 12, 2012
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
1
Review Days
454
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Basic Information
- Device Name
- CRYOTOP
- K Number
- K112695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kitazato Biopharma Co;Ltd
- Date Received
- September 15, 2011
- Decision Date
- December 12, 2012
- Product Code
- MQK
- 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 |
|---|---|---|---|
| MQK | Labware, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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