FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MD-2 IONTOPHORESIS UNIT
K Number: K895365
·
Decision Jun 26, 1990
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
13
Review Days
302
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Basic Information
- Device Name
- MD-2 IONTOPHORESIS UNIT
- K Number
- K895365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Unknown
- Applicant
- R. A. Fischer Co. Corp.
- Date Received
- August 28, 1989
- Decision Date
- June 26, 1990
- 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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Other Clearances by R. A. Fischer Co. Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K893389 | MODEL SE-5 EPILATOR | Jun 5, 1989 | Substantially Equivalent |
| K884079 | MODEL CBX EPILATOR | Oct 4, 1988 | Substantially Equivalent |
| K871372 | CB-7 ELECTRONIC EPILATOR | Apr 28, 1987 | Substantially Equivalent |
| K852534 | ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 | Nov 8, 1985 | Substantially Equivalent |
| K843063 | ELECTRONIC EPILATOR TS-1 | Sep 26, 1984 | Substantially Equivalent |
| K823674 | HIGH FREQUENCY EPILATOR CB-2 | Jan 14, 1983 | Substantially Equivalent |
| K801351 | EPILATOR, MODEL CP-16 | Jul 28, 1980 | Substantially Equivalent |
| K780076 | EPILATOR, ELECTRONIC MODEL SE-2 | Jan 24, 1978 | Substantially Equivalent |