The following data is part of a premarket notification filed by Reichert, Inc. with the FDA for Psl Portable Slit Lamp.
| Device ID | K061330 |
| 510k Number | K061330 |
| Device Name: | PSL PORTABLE SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | REICHERT, INC. 3374 WALDEN AVE. Depew, NY 14043 |
| Contact | Sandra Brown |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-12 |
| Decision Date | 2006-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010498 | K061330 | 000 |