FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH VELOCITY CW DOPPLER SYSTEM
K Number: K862841
·
Decision Nov 10, 1986
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
39
Review Days
104
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Basic Information
- Device Name
- HIGH VELOCITY CW DOPPLER SYSTEM
- K Number
- K862841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biosound, Inc.
- Date Received
- July 29, 1986
- Decision Date
- November 10, 1986
- 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 Biosound, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Jul 9, 1997 | Substantially Equivalent |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Mar 31, 1997 | Substantially Equivalent |
| K963262 | ARTOSCAN M | Mar 28, 1997 | Substantially Equivalent |
| K963662 | GALILEO EVOKED POTENTIALRE | Feb 26, 1997 | Substantially Equivalent |
| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 8, 1996 | Substantially Equivalent |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 1, 1996 | Substantially Equivalent |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 1, 1996 | Substantially Equivalent |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent |
| K953579 | TEE PROBE | Feb 2, 1996 | Substantially Equivalent |