FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSYS FETAL MONITOR, MODEL IFM-500
K Number: K994008
·
Decision Sep 29, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
1
Review Days
310
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
- BIOSYS FETAL MONITOR, MODEL IFM-500
- K Number
- K994008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosys Co. , Ltd.
- Date Received
- November 24, 1999
- Decision Date
- September 29, 2000
- 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 |
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