FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
K Number: K001995
·
Decision Sep 8, 2000
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
7
Review Days
70
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Basic Information
- Device Name
- SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
- K Number
- K001995
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qrs Diagnostic, LLC
- Date Received
- June 30, 2000
- Decision Date
- September 8, 2000
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | 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 |
| K031964 | BPCARD | Sep 5, 2003 | Substantially Equivalent |
| K030535 | EKGCARD SYSTEM | Jun 11, 2003 | Substantially Equivalent |
| K001278 | SENSAIRE DIAGNOSTIC SPIROMETER | Nov 29, 2000 | Substantially Equivalent |
| K973138 | SPIROCARD | Oct 28, 1998 | Substantially Equivalent |