FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ES-1000SP II SMART DOP
K Number: K903026
·
Decision Feb 26, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
8
Review Days
231
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Basic Information
- Device Name
- ES-1000SP II SMART DOP
- K Number
- K903026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Koven and Assoc., Inc.
- Date Received
- July 10, 1990
- Decision Date
- February 26, 1991
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Koven and Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922669 | MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW | Jan 29, 1993 | Substantially Equivalent |
| K920333 | SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR | Jan 22, 1993 | Substantially Equivalent |
| K915550 | MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR | Dec 10, 1992 | Substantially Equivalent |
| K913595 | DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Mar 27, 1992 | Substantially Equivalent |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | Dec 23, 1991 | Substantially Equivalent |
| K894892 | HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM | Oct 27, 1989 | Substantially Equivalent |
| K892707 | DVM-4200 BLOOD FLOWMETER | Jul 28, 1989 | Substantially Equivalent |