FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P-2 ULTRASONIC ARTERIOGRAPH
K Number: K792015
·
Decision Dec 4, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
19
Review Days
60
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Basic Information
- Device Name
- P-2 ULTRASONIC ARTERIOGRAPH
- K Number
- K792015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- D. E. Hokanson, Inc.
- Date Received
- October 5, 1979
- Decision Date
- December 4, 1979
- Product Code
- DPT
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by D. E. Hokanson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | Aug 6, 2004 | Substantially Equivalent |
| K033156 | OB1 OBSTETRICAL DOPPLER | Dec 9, 2003 | Substantially Equivalent |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | Feb 12, 2003 | Substantially Equivalent |
| K982707 | EC6 PLETHYSMOGRAPH | Aug 26, 1998 | Substantially Equivalent |
| K973426 | ANS 2000 ECG MONITOR AND RESPIRATION PACER | Aug 12, 1998 | Substantially Equivalent |
| 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 |