MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
FDA 510(k) clearance K014044 · decided 2002-03-04
Clearance details
- K-number
- K014044
- Device name
- MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
- Applicant
- Notal Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-07
- Decision date
- 2002-03-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HOQ
- Device class
- 1
- Regulation number
- 886.1330
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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| KREDA DISC (K874252) | Richmond Products, Inc. | 1988-01-27 |
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| MACULAR FUNCTION ANALYZER (K843227) | Danek Medical, Inc. | 1985-07-22 |
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Recalls involving this device
No recalls on record reference this clearance.