FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OB-1 FETAL MONITOR
K Number: K011304
·
Decision May 29, 2001
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
32
Review Days
29
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
- OB-1 FETAL MONITOR
- K Number
- K011304
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Analogic Corp.
- Date Received
- April 30, 2001
- Decision Date
- May 29, 2001
- 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
Other Clearances by Analogic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 | Jun 21, 2007 | Substantially Equivalent |
| K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 | Sep 21, 2005 | Substantially Equivalent |
| 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 |
| K002503 | FETALGARD LITE | Nov 9, 2000 | Substantially Equivalent |