FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-SCAN 10 MHZ PROBE
K Number: K896038
·
Decision Apr 23, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
18
Review Days
189
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Basic Information
- Device Name
- B-SCAN 10 MHZ PROBE
- K Number
- K896038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Teknar, Inc.
- Date Received
- October 16, 1989
- Decision Date
- April 23, 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)
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ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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Ultrasound Transducer Cover
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 Teknar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903666 | OPHTHASONIC A/P III | Nov 19, 1990 | Substantially Equivalent |
| K896150 | IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC | Jan 18, 1990 | Substantially Equivalent |
| K891777 | PRO-CUT BIOPSY NEEDLE | May 4, 1989 | Substantially Equivalent |
| K883965 | PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR | Oct 5, 1988 | Substantially Equivalent |
| K881850 | TEKNAR PERCU-SCAN | Aug 29, 1988 | Substantially Equivalent |
| K881605 | BIOPSY GUIDE | Jun 21, 1988 | Substantially Equivalent |
| K880659 | TEKNAR PROSCAN ACCESSORY PROBE | Apr 14, 1988 | Substantially Equivalent |
| K871536 | OPHTHASONIC A-SCAN/ B-SCAN | Aug 26, 1987 | Substantially Equivalent for Some Indications |
| K864807 | TEKNAR PROSCAN(TM) | Jul 10, 1987 | Substantially Equivalent |
| K860757 | OPHTHASONIC A-SCAN | Dec 18, 1986 | Substantially Equivalent |