The following data is part of a premarket notification filed by Ryazan State Instruments with the FDA for Tonometer Diaton.
Device ID | K060780 |
510k Number | K060780 |
Device Name: | TONOMETER DIATON |
Classification | Tonometer, Ac-powered |
Applicant | RYAZAN STATE INSTRUMENTS 151 EAST WALNUT STREET Long Beach, NY 11561 |
Contact | Boris Kun |
Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | HKX |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-03-22 |
Decision Date | 2006-04-06 |
Summary: | summary |