FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARCO STANDARD KERATOMETERS
K Number: K930444
·
Decision Aug 9, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
4
Applicant Total
15
Review Days
195
Basic Information
- Device Name
- MARCO STANDARD KERATOMETERS
- K Number
- K930444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1450
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MARCO OPHTHALMIC, INC.
- Date Received
- January 26, 1993
- Decision Date
- August 9, 1993
- Product Code
- HJB
- 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 |
|---|---|---|---|
| HJB | Instrument, Measuring, Corneal Radius | 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 |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930437 | MARCO STANDARD RADIUSGAUGES | Aug 9, 1993 | Substantially Equivalent |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | Jul 22, 1993 | Substantially Equivalent |
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | 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 |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Jul 6, 1993 | Substantially Equivalent |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Jul 6, 1993 | Substantially Equivalent |