The following data is part of a premarket notification filed by Randwal Instrument Co., Inc. with the FDA for Iras Glare Tester.
| Device ID | K873987 |
| 510k Number | K873987 |
| Device Name: | IRAS GLARE TESTER |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Contact | Cyr |
| Correspondent | Cyr RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-29 |
| Decision Date | 1987-11-24 |