FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSPACE
K Number: K131064
·
Decision Sep 4, 2013
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
9
Review Days
141
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Basic Information
- Device Name
- BIOSPACE
- K Number
- K131064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biospace Corporation Limited
- Date Received
- April 16, 2013
- Decision Date
- September 4, 2013
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Biospace Corporation Limited
| K Number | Device Name | ||
|---|---|---|---|
| K141483 | BIOSPACE BODY COMPOSITION ANALYZER | Sep 23, 2014 | Substantially Equivalent |
| K130777 | INBODY | Nov 25, 2013 | Substantially Equivalent |
| K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | Mar 8, 2013 | Substantially Equivalent |
| K110689 | INBODY | Aug 19, 2011 | Substantially Equivalent |
| K092786 | INBODY, MODELS: 270, R20, R20B | Mar 10, 2010 | Substantially Equivalent |
| K062603 | BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 | Feb 15, 2007 | Substantially Equivalent |
| K052646 | BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 | Dec 16, 2005 | Substantially Equivalent |
| K042528 | INBODY, MODEL 3.0 | Jan 11, 2005 | Substantially Equivalent |