FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MONICA AN24
K Number: K112390
·
Decision Jul 13, 2012
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
2
Review Days
330
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Basic Information
- Device Name
- MONICA AN24
- K Number
- K112390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Monica Healthcare, Ltd.
- Date Received
- August 18, 2011
- Decision Date
- July 13, 2012
- Product Code
- OSP
- 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 |
|---|---|---|---|
| OSP | Uterine Electromyographic Monitor | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Monica Healthcare, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Aug 27, 2014 | Substantially Equivalent |