FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MATRIX HOLTER SYSTEM, MODEL M12
K Number: K051730
·
Decision Sep 26, 2005
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
5
Review Days
91
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Basic Information
- Device Name
- MATRIX HOLTER SYSTEM, MODEL M12
- K Number
- K051730
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Global Instrumentation, LLC
- Date Received
- June 27, 2005
- Decision Date
- September 26, 2005
- Product Code
- MLO
- 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 |
|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | FDA class 2 | Cardiovascular |
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