Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1
FDA 510(k) K061848 · Hypermed, Inc.
510(k) numberK061848
Submission
- Device name
- Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1
- Applicant
- Hypermed, Inc.
Winchester, MA, US - Received
- June 30, 2006
- Decision date
- November 8, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code MUD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | Masimo Corporation | 07/17/2025SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemMUD · Special | 01/25/2008SE |
Questions and answers
When was Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 cleared by the FDA?
Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 (K061848) received a 510(k) decision of Substantially Equivalent on November 8, 2006, 131 days after the submission was received.
What is the product code of K061848?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.