FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEELER TEARSCOPE-PLUS
K Number: K973064
·
Decision Apr 7, 1998
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
60
Review Days
232
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Basic Information
- Device Name
- KEELER TEARSCOPE-PLUS
- K Number
- K973064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Keeler Instruments, Inc.
- Date Received
- August 18, 1997
- Decision Date
- April 7, 1998
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K100500 | PSL CLASSIC SLIT LAMP | Mar 9, 2010 | Substantially Equivalent |
| K062412 | CRYOMATIC | Nov 6, 2006 | Substantially Equivalent |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | May 23, 2006 | Substantially Equivalent |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Nov 26, 2003 | Substantially Equivalent |
| K992954 | KEELER CRYO MASTER & PROBES | Dec 21, 1999 | Substantially Equivalent |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Mar 25, 1999 | Substantially Equivalent |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Apr 2, 1997 | Substantially Equivalent |