FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K Number: K871869
·
Decision Aug 11, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
68
Review Days
90
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Basic Information
- Device Name
- MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
- K Number
- K871869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Unknown
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- May 13, 1987
- Decision Date
- August 11, 1987
- 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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| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |