COMPUTERIZED PUPIL
FDA 510(k) clearance K920937 · decided 1992-10-02
Clearance details
- K-number
- K920937
- Device name
- COMPUTERIZED PUPIL
- Applicant
- Trek Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-27
- Decision date
- 1992-10-02
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- HLG
- Device class
- 1
- Regulation number
- 886.1700
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Muckwonago, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PUPIL PATHWAY ANALYZER (PPA) (K895609) | Pulse Medical Instruments | 1989-11-02 |
| F110 PHOTO BINOCULAR OPHTHALMOSCOPE (K802351) | Minami, Tomine & Lew | 1980-12-17 |
Recalls involving this device
No recalls on record reference this clearance.