FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COSMED QUARK C12/QUARK T12
K Number: K014262
·
Decision Mar 26, 2002
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
10
Review Days
89
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Basic Information
- Device Name
- COSMED QUARK C12/QUARK T12
- K Number
- K014262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cosmed Srl
- Date Received
- December 27, 2001
- Decision Date
- March 26, 2002
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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| K093174 | SPIROPALM | Feb 26, 2010 | Substantially Equivalent |
| K071533 | FITMATE SERIES | Sep 28, 2007 | Substantially Equivalent |
| K040549 | COSMED PONY FX | Sep 28, 2004 | Substantially Equivalent |
| K020745 | COSMED MICROQUARK | Jan 2, 2003 | Substantially Equivalent |
| K001174 | COSMED QUARK | Jan 11, 2001 | Substantially Equivalent |
| K963373 | COSMED K4 | Sep 10, 1997 | Substantially Equivalent |