FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K Number: K950420
·
Decision May 15, 1995
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
32
Review Days
104
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Basic Information
- Device Name
- FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
- K Number
- K950420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Analogic Corp.
- Date Received
- January 31, 1995
- Decision Date
- May 15, 1995
- 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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Other Clearances by Analogic Corp.
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|---|---|---|---|
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| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P | Jun 14, 2005 | Substantially Equivalent |
| K043025 | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 | Nov 19, 2004 | Substantially Equivalent |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Aug 6, 2004 | Substantially Equivalent |
| K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A | Jul 20, 2004 | Substantially Equivalent |
| K040995 | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 | May 25, 2004 | Substantially Equivalent |
| K033345 | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS | Nov 19, 2003 | Substantially Equivalent |
| K030931 | C3 PATIENT MONITOR | May 9, 2003 | Substantially Equivalent |
| K011304 | OB-1 FETAL MONITOR | May 29, 2001 | Substantially Equivalent |