FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL MONITOR, MODELS BT-300 AND BT-200
K Number: K052190
·
Decision Oct 4, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
11
Review Days
54
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
- FETAL MONITOR, MODELS BT-300 AND BT-200
- K Number
- K052190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bistos Co., Ltd.
- Date Received
- August 11, 2005
- Decision Date
- October 4, 2005
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
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 Bistos Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251512 | Hi bebe super (BT-150B) | Sep 25, 2025 | Substantially Equivalent |
| K232991 | BT-1000 | Aug 28, 2024 | Substantially Equivalent |
| K210289 | Infant Phototherapy Equipment | May 28, 2021 | Substantially Equivalent |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | Feb 10, 2021 | Substantially Equivalent |
| K160274 | Hi bebe plus | Sep 1, 2016 | Substantially Equivalent |
| K142799 | Model BT-220L and BT-220C | Jul 9, 2015 | Substantially Equivalent |
| K132543 | INFANT INCUBATOR | Jul 3, 2014 | Substantially Equivalent |
| K121267 | BT-200V VASCULAR DOPPLER | Aug 2, 2012 | Substantially Equivalent |
| K103545 | BT-350 | May 13, 2011 | Substantially Equivalent |
| K100885 | FETAL MONITOR MODEL: BT-200T | Jun 7, 2010 | Substantially Equivalent |