FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUALIS
K Number: K133295
·
Decision Jun 18, 2014
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
1
Review Days
236
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Basic Information
- Device Name
- QUALIS
- K Number
- K133295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Menicon Co., Ltd. New Business Division
- Date Received
- October 25, 2013
- Decision Date
- June 18, 2014
- 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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