SedLine
SedLine Module
4manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Masimo Corporation, United States |
|---|---|
| FDA product code | OLW |
| Device type | Index-Generating Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K203113 |
| Record published | 2023-08-22 |
| Record revised | 2025-12-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4432 | In distribution | |
| 4497 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BIS | Covidien LP | 57 |
| RD Sedline | Masimo Corporation | 2 |
| EEG Module w/ Cable | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| B1X5 Software Upgrade | GE Medical Systems Information Technologies, Inc. | 1 |
| BIS Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| BIS module (w accessory kit) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| NeuroSENSE | Neurowave Systems Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260880 | 2026-07-10 |
| K203113 | 2022-02-25 |
| K172890 | 2018-01-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.