FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOSCAN WITH DOPPLER OPTION
K Number: K862913
·
Decision Nov 4, 1986
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
17
Review Days
95
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Basic Information
- Device Name
- CARDIOSCAN WITH DOPPLER OPTION
- K Number
- K862913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Interspec, Inc.
- Date Received
- August 1, 1986
- Decision Date
- November 4, 1986
- 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 Interspec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940671 | INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER | Nov 22, 1994 | Substantially Equivalent |
| K924231 | INTERSPEC APOGEE CLA | Jun 14, 1993 | Substantially Equivalent |
| K915696 | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE | Nov 24, 1992 | Substantially Equivalent |
| K920678 | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER | Apr 2, 1992 | Substantially Equivalent |
| K911073 | PROBE REFILL KIT | Jun 6, 1991 | Substantially Equivalent |
| K910049 | INTERSPEC APOGEE, MODIFICATION | Apr 29, 1991 | Substantially Equivalent |
| K903839 | INTERSPEC APOGEE | Nov 16, 1990 | Substantially Equivalent |
| K900155 | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER | Oct 5, 1990 | Substantially Equivalent |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | Jul 19, 1989 | Substantially Equivalent |
| K890173 | INTERSPEC APOGEE | Apr 14, 1989 | Substantially Equivalent |