Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)
FDA 510(k) K091452 · Cas Medical Systems, Inc.
510(k) numberK091452
Submission
- Device name
- Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)
- Applicant
- Cas Medical Systems, Inc.
Branford, CT, US - Received
- May 18, 2009
- Decision date
- August 21, 2009
- 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 |
|---|---|---|
| K190270 | FORE-SIGHT ELITE Tissue Oximeter ModuleMUD · Traditional | 10/21/2019SE |
| K180003 | FORE-SIGHT ELITE Module Tissue OximeterMUD · Traditional | 05/10/2018SE |
| K150620 | 740 SelectMWI · Traditional | 05/08/2015SE |
| K143675 | FORE-SIGHT Elite Absolute Tissue OximeterMUD · Traditional | 04/10/2015SE |
| K140430 | 740 SelectMWI · Traditional | 06/13/2014SE |
| K133879 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | 04/29/2014SE |
| K130411 | 740 SelectMWI · Traditional | 05/29/2013SE |
| K123700 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | 04/11/2013SE |
| K112820 | Fore-Sight Absolute Tissue OximeterMUD · Traditional | 01/26/2012SE |
| K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…MUD · Traditional | 12/23/2010SE |
Questions and answers
When was Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) cleared by the FDA?
Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) (K091452) received a 510(k) decision of Substantially Equivalent on August 21, 2009, 95 days after the submission was received.
What is the product code of K091452?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.