FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARCO STANDARD LENSMETERS 101,201
K Number: K930441
·
Decision Jul 6, 1993
Classifications
1
FEI Numbers
64
Registration Numbers
65
Same Product Code
15
Applicant Total
15
Review Days
161
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Basic Information
- Device Name
- MARCO STANDARD LENSMETERS 101,201
- K Number
- K930441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1425
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marco Ophthalmic, Inc.
- Date Received
- January 26, 1993
- Decision Date
- July 6, 1993
- Product Code
- HLM
- 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 |
|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Marco Ophthalmic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943234 | MS-30 AUTOMATIC PERIMETER | Jul 27, 1994 | Substantially Equivalent |
| K930437 | MARCO STANDARD RADIUSGAUGES | Aug 9, 1993 | Substantially Equivalent |
| K930444 | MARCO STANDARD KERATOMETERS | Aug 9, 1993 | Substantially Equivalent |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | Jul 22, 1993 | Substantially Equivalent |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Jul 6, 1993 | Substantially Equivalent |
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Jul 6, 1993 | Substantially Equivalent |
| K930446 | MARCO TRIAL SETS | Jul 6, 1993 | Substantially Equivalent |
| K930440 | MARCO INTERNATIONAL STAND | Jul 6, 1993 | Substantially Equivalent |