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 |