FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER
K Number: K900155
·
Decision Oct 5, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
17
Review Days
266
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Basic Information
- Device Name
- INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER
- K Number
- K900155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Interspec, Inc.
- Date Received
- January 12, 1990
- Decision Date
- October 5, 1990
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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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 |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | Jul 19, 1989 | Substantially Equivalent |
| K890173 | INTERSPEC APOGEE | Apr 14, 1989 | Substantially Equivalent |
| K862913 | CARDIOSCAN WITH DOPPLER OPTION | Nov 4, 1986 | Substantially Equivalent |