The following data is part of a premarket notification filed by Randwal Instrument Co., Inc. with the FDA for Iras Eds Interferometric Stimulator.
| Device ID | K873990 |
| 510k Number | K873990 |
| Device Name: | IRAS EDS INTERFEROMETRIC STIMULATOR |
| Classification | Photostimulator, Ac-powered |
| Applicant | RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Contact | Robert St.cyr |
| Correspondent | Robert St.cyr RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-01 |
| Decision Date | 1988-02-05 |