FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
K Number: K896034
·
Decision Jan 18, 1990
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
19
Review Days
94
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Basic Information
- Device Name
- PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
- K Number
- K896034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- D. E. Hokanson, Inc.
- Date Received
- October 16, 1989
- Decision Date
- January 18, 1990
- Product Code
- DSB
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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Other Clearances by D. E. Hokanson, Inc.
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| K970570 | NIVP3 (WINDOWS VERSION OF NIVP | Oct 3, 1997 | Substantially Equivalent |
| K932852 | NON INVASIVE VASCULAR PROGRAM | Feb 4, 1994 | Substantially Equivalent |
| K932812 | EC 5R PLETHYSMOGRAPH | Jan 13, 1994 | Substantially Equivalent |
| K932851 | DISPOSABLE PENILE BLOOD PRESSURE CUFFS | Nov 15, 1993 | Substantially Equivalent |
| K905367 | E-20 RAPID CUFF INFLATOR | Mar 6, 1991 | Substantially Equivalent |