FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYSONIC ULTRASOUND LOTION
K Number: K827296
·
Decision Apr 16, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
30
Review Days
17
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Basic Information
- Device Name
- POLYSONIC ULTRASOUND LOTION
- K Number
- K827296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- March 30, 1982
- Decision Date
- April 16, 1982
- Product Code
- MUI
- 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 |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
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| 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 |