The following data is part of a premarket notification filed by Precision Optics Corp. with the FDA for Precision Optics Corporation Video Ophthalmoscope, Model 2500-vos.
| Device ID | K053425 |
| 510k Number | K053425 |
| Device Name: | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
| Contact | Erwin Heider |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-01-09 |
| Summary: | summary |