The following data is part of a premarket notification filed by Trek Medical Products, Inc. with the FDA for Computerized Pupil.
| Device ID | K920937 |
| 510k Number | K920937 |
| Device Name: | COMPUTERIZED PUPIL |
| Classification | Pupillometer, Ac-powered |
| Applicant | TREK MEDICAL PRODUCTS, INC. 820 SWAN DR. P.O. BOX B Mukwonago, WI 53149 |
| Contact | Ronald Hueneke |
| Correspondent | Ronald Hueneke TREK MEDICAL PRODUCTS, INC. 820 SWAN DR. P.O. BOX B Mukwonago, WI 53149 |
| Product Code | HLG |
| CFR Regulation Number | 886.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1992-10-02 |