The following data is part of a premarket notification filed by Sony Electronics Inc. with the FDA for Sony Ip Converter Nu-ip40s.
Device ID | K161122 |
510k Number | K161122 |
Device Name: | Sony IP Converter NU-IP40S |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SONY ELECTRONICS INC. 1 SONY DRIVE Park Ridge, NJ 07656 |
Contact | Amarjit 'andy' Jowandha |
Correspondent | Amarjit 'andy' Jowandha SONY ELECTRONICS INC. 1 SONY DRIVE 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 | 2016-04-21 |
Decision Date | 2016-06-08 |
Summary: | summary |