FDA device listing

HMS-3000MT SONY Monitor,LMD-2435MD SONY Monitor,LMD-2435NB SONY Monitor,LMD-2451MT SONY Monitor,LMD-2735MD SONY…

FDA device listing 1587507716 · Sony Corporation

Key facts

Proprietary names HMS-3000MT SONY Monitor,LMD-2435MD SONY Monitor,LMD-2435NB SONY Monitor,LMD-2451MT SONY Monitor,LMD-2735MD SONY Monitor,LMD-2735NB SONY Monitor,LMD-3251MT SONY Monitor,LMD-3251ST SONY Monitor
Owner/operator Sony Corporation
Owner/operator number 9078461
Premarket submissions K113203
Product codes GCJ
Device names GCJ - Laparoscope, General & Plastic Surgery
Device class Class II
Classification regulations (21 CFR) 876.1500
Review panels Gastroenterology & Urology
Registered establishments Sony Corporation, Sony Global Manufacturing & Operations Corporation Kohda Site
Establishment registrations 3004091527, 3016527960
FEI numbers 3004091527, 3016527960
Establishment operations Complaint File Establishment, Specification Developer, Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings