FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K Number: K100797
·
Decision Nov 10, 2010
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
210
Applicant Total
47
Review Days
233
Basic Information
- Device Name
- FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
- K Number
- K100797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EDAN INSTRUMENTS, INC.
- Date Received
- March 22, 2010
- Decision Date
- November 10, 2010
- Product Code
- HGM
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K152427 | PC ECG | Feb 5, 2016 | Substantially Equivalent |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Jan 29, 2016 | Substantially Equivalent |
| K151787 | Holter System | Jan 27, 2016 | Substantially Equivalent |
| K151878 | Video Colposcope | Dec 1, 2015 | Substantially Equivalent |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Jul 1, 2015 | Substantially Equivalent |