The following data is part of a premarket notification filed by Sony Electronics, Inc. with the FDA for Sony Lmd-x310s Lcd Monitor, Sony Lmd-x310md Lcd Monitor, Sony Lmd-x310nb Lcd Monitor, Sony Lmd-x550s Lcd Monitor, Sony Lmd-x550md Lcd, Sony Lmd-x550nb Lcd Monitor.
Device ID | K150377 |
510k Number | K150377 |
Device Name: | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SONY ELECTRONICS, INC. 1 Sony Drive, Mail Stop 3C5 Park Ridge, NJ 07656 |
Contact | Amarjit Andy Singh Jowandha |
Correspondent | Amarjit Andy Singh Jowandha SONY ELECTRONICS, INC. 1 Sony Drive, Mail Stop 3C5 Park Ridge, NJ 07656 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-13 |
Decision Date | 2015-07-29 |
Summary: | summary |