The following data is part of a premarket notification filed by Sony Electronics Inc. with the FDA for Ip Converter.
Device ID | K191678 |
510k Number | K191678 |
Device Name: | IP Converter |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Sony Electronics Inc. 115 West Century Road, Suite 250 Paramus, NJ 07652 |
Contact | Shogo Obuchi |
Correspondent | Tomomichi Iwasaka Sony Corporation, Atsugi Technology Center 4-14-1 Asahi-cho Atsugi-shi, JP 243-0014 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-24 |
Decision Date | 2020-01-10 |