FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FM-1000 PLUS FETAL MONITOR
K Number: K112187
·
Decision Sep 21, 2011
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
16
Review Days
54
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Basic Information
- Device Name
- FM-1000 PLUS FETAL MONITOR
- K Number
- K112187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Instrumentations, Inc.
- Date Received
- July 29, 2011
- Decision Date
- September 21, 2011
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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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Other Clearances by Advanced Instrumentations, Inc.
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| K141194 | FM-3000 FETAL MONITOR | Nov 19, 2014 | Substantially Equivalent |
| K132077 | PATIENT MONITOR | Apr 23, 2014 | Substantially Equivalent |
| K132059 | DIAGNOSTIC ULTRASOUND SYSTEM | Oct 25, 2013 | Substantially Equivalent |
| K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO | Jan 11, 2013 | Substantially Equivalent |
| K120075 | AM-6000 ANESTHESIA MACHINE | Jan 26, 2012 | Substantially Equivalent |
| K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR | Dec 21, 2011 | Substantially Equivalent |
| K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER | Oct 27, 2011 | Substantially Equivalent |
| K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER | Sep 22, 2011 | Substantially Equivalent |