FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BPCARD
K Number: K031964
·
Decision Sep 5, 2003
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
7
Review Days
72
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Basic Information
- Device Name
- BPCARD
- K Number
- K031964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qrs Diagnostic, LLC
- Date Received
- June 25, 2003
- Decision Date
- September 5, 2003
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Qrs Diagnostic, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K083749 | CARDIOVIEW32 REVIEW MODULE | Mar 10, 2009 | Substantially Equivalent |
| K073630 | MODIFICATION TO: BPCARD, MODEL Z-7000-0700 | Jan 11, 2008 | Substantially Equivalent |
| K030535 | EKGCARD SYSTEM | Jun 11, 2003 | Substantially Equivalent |
| K001278 | SENSAIRE DIAGNOSTIC SPIROMETER | Nov 29, 2000 | Substantially Equivalent |
| K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER | Sep 8, 2000 | Substantially Equivalent |
| K973138 | SPIROCARD | Oct 28, 1998 | Substantially Equivalent |