FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
K Number: K010482
·
Decision Mar 20, 2001
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
6
Review Days
28
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Basic Information
- Device Name
- ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
- K Number
- K010482
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Echocath, Inc.
- Date Received
- February 20, 2001
- Decision Date
- March 20, 2001
- Product Code
- JOP
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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Other Clearances by Echocath, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Sep 16, 1999 | Substantially Equivalent |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | Nov 16, 1995 | Substantially Equivalent |
| K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER | May 4, 1995 | Substantially Equivalent |
| K926351 | COLORMARK(TM) VISUALIZATION SYSTEM | Sep 16, 1993 | Substantially Equivalent |
| K922787 | ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION | Jan 6, 1993 | Substantially Equivalent |