FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOMEY DTL ELECTRODE
K Number: K961805
·
Decision May 9, 1997
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
10
Applicant Total
9
Review Days
364
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Basic Information
- Device Name
- TOMEY DTL ELECTRODE
- K Number
- K961805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1220
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomey Corporation USA
- Date Received
- May 10, 1996
- Decision Date
- May 9, 1997
- Product Code
- HLZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HLZ | Electrode, Corneal | FDA class 2 | Ophthalmic |
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Other Clearances by Tomey Corporation USA
| K Number | Device Name | ||
|---|---|---|---|
| K971953 | CONFOSCAN | Aug 14, 1997 | Substantially Equivalent |
| K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | Jun 24, 1997 | Substantially Equivalent |
| K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 | Aug 31, 1995 | Substantially Equivalent |
| K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 | Mar 1, 1995 | Substantially Equivalent |
| K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE | Nov 22, 1994 | Substantially Equivalent |
| K924760 | TOMEY PROTON TONOMETER | Apr 5, 1993 | Substantially Equivalent |
| K921815 | TOMEY PE-300 PORTABLE ERG | Jul 15, 1992 | Substantially Equivalent |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Jun 17, 1991 | Substantially Equivalent |