FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K Number: K802146
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
345
Registration Numbers
346
Same Product Code
883
Applicant Total
29
Review Days
35
Basic Information
- Device Name
- AQUASONIC 100 ULTRASOUND TRANS. GEL,
- K Number
- K802146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- PARKER LABORATORIES, INC.
- Date Received
- September 5, 1980
- Decision Date
- October 10, 1980
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
B-Scan
FDA 510(k)
FDA Class 2
·Radiology
Velacur One (LI-1100)
FDA 510(k)
FDA Class 2
·Radiology
Accuro 3S
FDA 510(k)
FDA Class 2
·Radiology
EchoGuide (Version 1)
FDA 510(k)
FDA Class 2
·Radiology
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
FDA 510(k)
FDA Class 2
·Radiology
SpineUs System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by PARKER LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | 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 |