FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
K Number: K100626
·
Decision May 21, 2010
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
5
Review Days
77
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
- DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
- K Number
- K100626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Biocare Electronics Co., Ltd.
- Date Received
- March 5, 2010
- Decision Date
- May 21, 2010
- Product Code
- KNG
- 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 |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNG), ordered by most recent decision date.
Fetal Doppler U8-25, U9-25
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Doppler FHR Detector (BF-500D+, BF-560)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultrasonic Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Shenzhen Biocare Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K123816 | DIGITAL ELECTROCARDIOGRAPHS | Feb 27, 2013 | Substantially Equivalent |
| K122712 | DIGITAL ELECTROCARDIOGRAPH | Oct 25, 2012 | Substantially Equivalent |
| K112431 | DIGITAL ELECTROCARDIOGRAPH | Sep 22, 2011 | Substantially Equivalent |
| K101876 | DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 | Mar 1, 2011 | Substantially Equivalent |