FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
K Number: K100813
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
3
Review Days
122
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Basic Information
- Device Name
- QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
- K Number
- K100813
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulse Biomedical, Inc.
- Date Received
- March 23, 2010
- Decision Date
- July 23, 2010
- 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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