FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
K Number: K921695
·
Decision Feb 23, 1995
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
30
Review Days
1051
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Basic Information
- Device Name
- ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
- K Number
- K921695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Parker Laboratories, Inc.
- Date Received
- April 8, 1992
- Decision Date
- February 23, 1995
- 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
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
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Other Clearances by Parker Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Aug 15, 2024 | Substantially Equivalent |
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |
| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 | Substantially Equivalent |