The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Ritter Model 158 And 159 Exam Lights.
Device ID | K932719 |
510k Number | K932719 |
Device Name: | RITTER MODEL 158 AND 159 EXAM LIGHTS |
Classification | Device, Medical Examination, Ac Powered |
Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Contact | K Seiden |
Correspondent | K Seiden MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-04 |
Decision Date | 1993-12-02 |