FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIOVIEW32 REVIEW MODULE
K Number: K083749
·
Decision Mar 10, 2009
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
7
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARDIOVIEW32 REVIEW MODULE
- K Number
- K083749
- Clearance Type
- Special
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qrs Diagnostic, LLC
- Date Received
- December 17, 2008
- Decision Date
- March 10, 2009
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Qrs Diagnostic, LLC
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER | Sep 8, 2000 | Substantially Equivalent |
| K973138 | SPIROCARD | Oct 28, 1998 | Substantially Equivalent |