FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PVR-100/VASOGRAM
K Number: K990123
·
Decision Apr 12, 1999
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- PVR-100/VASOGRAM
- K Number
- K990123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2780
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vasocor, Inc.
- Date Received
- January 13, 1999
- Decision Date
- April 12, 1999
- Product Code
- JOM
- 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 |
|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | FDA class 2 | Cardiovascular |
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