FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K Number: K830215
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
46
Applicant Total
92
Review Days
44
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Basic Information
- Device Name
- DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
- K Number
- K830215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Jedmed Instrument Co.
- Date Received
- January 24, 1983
- Decision Date
- March 9, 1983
- Product Code
- HLJ
- 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 |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | FDA class 2 | Ophthalmic |
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| K950925 | JEDMED LARYNGEAL SCOPE | Aug 11, 1995 | Substantially Equivalent |
| K953457 | JEDMED SPECTRUM ENT CABINET | Aug 11, 1995 | Substantially Equivalent |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jun 28, 1995 | Substantially Equivalent |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jun 21, 1995 | Substantially Equivalent |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | Feb 7, 1995 | Substantially Equivalent |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Sep 23, 1994 | Substantially Equivalent |