O3
O3 Sensor Infant/Neonatal Adhesive Sensor
5manufacturers in China registered for this device type
5catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Masimo Corporation, United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-10-08 |
| Record revised | 2026-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -40 to 60 °C; Handling environment humidity 15 to 95 % RH; Handling environment temperature -40 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4616 | In distribution | ||
| 4496 | In distribution | ||
| 4431 | In distribution | ||
| 4315 | In distribution | ||
| 4384 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243324 | 2025-07-17 |
| K214072 | 2022-05-06 |
| K201432 | 2020-08-29 |
| K182429 | 2019-06-07 |
| K162603 | 2017-05-26 |
| K160526 | 2016-06-09 |
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.