FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHASE CARDIAC ANALYSIS SYSTEM
K Number: K032531
·
Decision Feb 2, 2004
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
27
Review Days
171
Basic Information
- Device Name
- CHASE CARDIAC ANALYSIS SYSTEM
- K Number
- K032531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CHASE MEDICAL, INC.
- Date Received
- August 15, 2003
- Decision Date
- February 2, 2004
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by CHASE MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K022093 | CHASE CARDIOVASCULAR PATCH KIT | Sep 20, 2002 | Substantially Equivalent |
| K021129 | CHARE CARIOVASCULAR PATCH | Jun 3, 2002 | Substantially Equivalent |
| K020233 | CHASE CARDIOVASCULAR PATCH KIT | Mar 14, 2002 | Substantially Equivalent |
| K020132 | CHASE CARDIOVASCULAR PATCH KIT | Feb 26, 2002 | Substantially Equivalent |
| K012248 | CHASE CARDIOVASCULAR PATCH | Aug 10, 2001 | Substantially Equivalent |
| K003467 | CHASE CARDIOVASCULAR PATCH | Jan 29, 2001 | Substantially Equivalent |
| K001662 | CHASE CARDIOVASCULAR PATCH | Aug 2, 2000 | Substantially Equivalent |
| K972993 | CHASE FEMORAL ACCESS CANNULATION SET | Mar 31, 1998 | Substantially Equivalent |
| K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | Jan 6, 1998 | Substantially Equivalent |
| K971013 | CHASE TEMPERATURE PROBE | Oct 28, 1997 | Substantially Equivalent |