FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESENSITRON
K Number: K771130
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
29
Review Days
22
Basic Information
- Device Name
- DESENSITRON
- K Number
- K771130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- PARKER LABORATORIES, INC.
- Date Received
- June 23, 1977
- Decision Date
- July 15, 1977
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
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| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 | Substantially Equivalent |