FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K Number: K010505
·
Decision Mar 9, 2001
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
7
Review Days
16
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Basic Information
- Device Name
- TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
- K Number
- K010505
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brentwood Medical Technology Corp.
- Date Received
- February 21, 2001
- Decision Date
- March 9, 2001
- 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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| K052898 | IQMARK EZ STRESS | Mar 28, 2006 | Substantially Equivalent |
| K031466 | IQMARK DIGITAL HOLTER | Jun 11, 2003 | Substantially Equivalent |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | Feb 6, 2002 | Substantially Equivalent |
| K002499 | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE | Nov 8, 2000 | Substantially Equivalent |