FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K Number: K024323
·
Decision Jun 30, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
2
Review Days
186
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Basic Information
- Device Name
- CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
- K Number
- K024323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Systems Corp.
- Date Received
- December 26, 2002
- Decision Date
- June 30, 2003
- 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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Other Clearances by Biomedical Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K100155 | TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM | Apr 20, 2010 | Substantially Equivalent |