FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
TRANSTEK GLASS BODY FAT ANALYZER
K Number: K123781
·
Decision Jan 9, 2013
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- TRANSTEK GLASS BODY FAT ANALYZER
- K Number
- K123781
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhongshan Transtek Electronics Co., Ltd.
- Date Received
- December 10, 2012
- Decision Date
- January 9, 2013
- Product Code
- MNW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MNW | Analyzer, Body Composition | FDA class 2 | Cardiovascular |
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Other Clearances by Zhongshan Transtek Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K123780 | TRANSTEK BLOOD PRESSURE MONITOR | Mar 1, 2013 | Substantially Equivalent |
| K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Dec 21, 2012 | Substantially Equivalent |
| K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Oct 22, 2012 | Substantially Equivalent |
| K121971 | WITHINGS, SMART BODY SCALE | Sep 27, 2012 | Substantially Equivalent |
| K120058 | TRANSTEK BLOOD PRESSURE MONITOR | Jan 31, 2012 | Substantially Equivalent |
| K112932 | TRANSTEK | Nov 1, 2011 | Substantially Equivalent |
| K101681 | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | May 27, 2011 | Substantially Equivalent |
| K102191 | TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER | May 2, 2011 | Substantially Equivalent |