FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQMARK DIGITAL HOLTER
K Number: K031466
·
Decision Jun 11, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- IQMARK DIGITAL HOLTER
- K Number
- K031466
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brentwood Medical Technology Corp.
- Date Received
- May 8, 2003
- Decision Date
- June 11, 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 Brentwood Medical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103640 | MIDMARK IQECG | Mar 22, 2011 | Substantially Equivalent |
| K100913 | IQVITALS AND IQVITALS SYSTEM | May 26, 2010 | Substantially Equivalent |
| K052898 | IQMARK EZ STRESS | Mar 28, 2006 | Substantially Equivalent |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | Feb 6, 2002 | Substantially Equivalent |
| K010505 | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | Mar 9, 2001 | Substantially Equivalent |
| K002499 | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE | Nov 8, 2000 | Substantially Equivalent |