FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K Number: K080884
·
Decision Apr 11, 2008
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
2
Review Days
11
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Basic Information
- Device Name
- QHRV 1 - HEALTH ASSESSMENT SYSTEM
- K Number
- K080884
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtechs, LLC
- Date Received
- March 31, 2008
- Decision Date
- April 11, 2008
- Product Code
- DPS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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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Other Clearances by Medtechs, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Feb 18, 2009 | Substantially Equivalent |