FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
K Number: K901725
·
Decision Aug 15, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
6
Review Days
121
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Basic Information
- Device Name
- ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
- K Number
- K901725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Kretztechnik AG
- Date Received
- April 16, 1990
- Decision Date
- August 15, 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
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
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ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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Accuro® 3S Needle Guide Kit
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FDA 510(k)
FDA Class 2
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UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
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Other Clearances by Kretztechnik AG
| K Number | Device Name | ||
|---|---|---|---|
| K925354 | COMBISON(R) 311 | Jul 8, 1993 | Substantially Equivalent |
| K904070 | COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A | Oct 9, 1992 | Substantially Equivalent |
| K910966 | SECTOR TRANSDUCER MODEL NO. AWP3.5/A | Apr 17, 1992 | Substantially Equivalent |
| K904665 | MODEL IW17.5A INTRA OPERATIVE TRANSDUCER | Jan 11, 1991 | Substantially Equivalent |
| K901655 | 1 TRANSDUCER FOR COMBISON 310A | Jul 20, 1990 | Substantially Equivalent |