The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 20.1 Inch (51cm) Monochrome Lcd Monitor Me205 (ml20205).
Device ID | K143076 |
510k Number | K143076 |
Device Name: | 20.1 Inch (51cm) Monochrome LCD Monitor ME205 (ML20205) |
Classification | Display, Diagnostic Radiology |
Applicant | JVC KENWOOD CORPORATION 3-12 MORIYA-CHO, KANAGAWA-KU Yokohama-shi, JP 221-0022 |
Contact | Tsukasa Tashiro |
Correspondent | Tsukasa Tashiro JVC KENWOOD CORPORATION 3-12 MORIYA-CHO, KANAGAWA-KU Yokohama-shi, JP 221-0022 |
Product Code | PGY |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-27 |
Decision Date | 2014-11-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04996005103432 | K143076 | 000 |