FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vit Kit- Freeze NX and Vit Kit- Warm NX
K Number: K190152
·
Decision Jun 21, 2019
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
1
Review Days
142
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Basic Information
- Device Name
- Vit Kit- Freeze NX and Vit Kit- Warm NX
- K Number
- K190152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Irvine Scientific, Inc.
- Date Received
- January 30, 2019
- Decision Date
- June 21, 2019
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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