The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Psl Classic Slit Lamp.
| Device ID | K100500 |
| 510k Number | K100500 |
| Device Name: | PSL CLASSIC SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene Vanarsdale |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272711890 | K100500 | 000 |
| 05055272711777 | K100500 | 000 |
| 05055272711388 | K100500 | 000 |