510(k) K211561
- Device
- INVOS PM7100 Patient Monitor, INVOS Pediatric RSO2 Sensor, INVOS Infant Regional Saturation Sensor (also Referred To As OxyAlert NIRSensor)
- Applicant
- Covidien, Llc
- 510(k) number
- K211561
- Product code
- MUD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-05
- Date received
- 2021-05-20
- Regulation
- 870.2700
- Classification name
- Oximeter, Tissue Saturation
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Megan Elliott
- Address
- 6135 Gunbarrel Ave. Boulder CO US 80301 80301
FDA Registration Numbers#
- 2648045
- 3021337298
- 3012359877
- 3042025620
- 3003965364
- 1000314502
- 8020893
- 3007603826
- 3032916632
- 3018094310
- 8030476
- 3021343210
- 2024311
- 3013436077
- 9610105
- 2936999
- 3011369688
- 3001570235
- 3008717564
- 9614683
- 3008202779
- 9615817
- 3018940143
- 3013679558
- 3008058135
- 2221819
- 1018233
- 3013557562
- 3007137598
- 9710602
- 3009673645
- 3010611950
- 1651104
- 3004832480
- 2183646
- 3006161756
- 3019388613
- 3004105270
- 3009156722
- 3042165671
- 3011353843
- 3009771004
- 3037724692
- 3007616088
- 3042225166
- 8043564
- 9610816
- 3013500228
- 3009906207
- 2011171
- 3004415095
- 3008729547
- 3013596024
- 3013944123
- 2133641
- 3006082230
Source Documents#
Other 510(k) Records For Product Code MUD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254129 | Spectrum-2 | Neko Health AB | 2026-05-22 |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025-07-17 |
| K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | ViOptix, Inc. | 2025-06-26 |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024-10-16 |
| K241393 | ODI-Tech | Odi Medical AS | 2024-08-30 |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | 2024-04-02 |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024-03-01 |
| K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024-02-28 |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023-11-17 |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023-05-26 |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022-05-06 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022-05-03 |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021-02-10 |
| K201976 | SnapshotNIR | Kent Imaging | 2020-11-10 |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020-08-29 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases