FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
OTOSCOPE A-34
K Number: K950788
·
Decision May 3, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
24
Review Days
71
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Basic Information
- Device Name
- OTOSCOPE A-34
- K Number
- K950788
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neitz Instruments Company, Ltd.
- Date Received
- February 21, 1995
- Decision Date
- May 3, 1995
- Product Code
- ERA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Neitz Instruments Company, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K972440 | CATARACTSCREENER CT - S | Sep 30, 1997 | Substantially Equivalent |
| K951341 | NEITZ SLIT LAMP SL-H2 | Jun 15, 1995 | Substantially Equivalent |
| K951337 | FIBER HEAD LIGHT FH-300 | Jun 8, 1995 | Substantially Equivalent |
| K951340 | NEITZ SLIT LAMP SL-H1 | Apr 10, 1995 | Substantially Equivalent |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Apr 7, 1995 | Substantially Equivalent |
| K950792 | STREAK RETINOSCOPE RX-3A | Mar 28, 1995 | Substantially Equivalent |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Mar 28, 1995 | Substantially Equivalent |
| K950793 | SPOT RETINOSCOPE RX-3SP | Mar 28, 1995 | Substantially Equivalent |
| K950789 | STREAK RETINOSCOPE RX-1 | Mar 28, 1995 | Substantially Equivalent |
| K950794 | STREAK RETINOSCOPE RX-RC | Mar 28, 1995 | Substantially Equivalent |