FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FM20
K Number: K110612
·
Decision Nov 8, 2011
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
10
Review Days
250
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FM20
- K Number
- K110612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediana Co., Ltd.
- Date Received
- March 3, 2011
- Decision Date
- November 8, 2011
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGM), ordered by most recent decision date.
ANNE Maternal
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonicaid Team3
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fetal & Maternal Monitor (F15A, F15A Air)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonicaid Team3
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PeriCALM Patterns 3.0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Mediana Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K200434 | V20, V20a, AVSM3 SNF | Oct 9, 2020 | Substantially Equivalent |
| K170497 | V10 | Dec 15, 2017 | Substantially Equivalent |
| K160358 | DT-100 | Feb 24, 2017 | Substantially Equivalent |
| K152659 | V10 | Aug 25, 2016 | Substantially Equivalent |
| K112190 | PATIENT MONITOR | Nov 9, 2011 | Substantially Equivalent |
| K110630 | F10 | Jun 24, 2011 | Substantially Equivalent |
| K100225 | PULSE OXIMETER MODEL P10 | Feb 9, 2011 | Substantially Equivalent |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | Jun 8, 2010 | Substantially Equivalent |
| K051375 | VITAL SIGNS MONITOR | Jul 28, 2005 | Substantially Equivalent |