The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Wide Angle Ophthalmoscope Model 1130-p-5004.
| Device ID | K032087 |
| 510k Number | K032087 |
| Device Name: | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene Vanarsdale |
| Correspondent | Eugene Vanarsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-11-26 |
| Summary: | summary |