FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROBE REFILL KIT
K Number: K911073
·
Decision Jun 6, 1991
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
17
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROBE REFILL KIT
- K Number
- K911073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Interspec, Inc.
- Date Received
- March 11, 1991
- Decision Date
- June 6, 1991
- 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
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |
| K862913 | CARDIOSCAN WITH DOPPLER OPTION | Nov 4, 1986 | Substantially Equivalent |