Essential MRI Patient Monitor
FDA 510(k) K103700 · Invivo Corporation
510(k) numberK103700
Submission
- Device name
- Essential MRI Patient Monitor
- Applicant
- Invivo Corporation
Orlando, FL, US - Received
- December 20, 2010
- Decision date
- March 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
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Questions and answers
When was Essential MRI Patient Monitor cleared by the FDA?
Essential MRI Patient Monitor (K103700) received a 510(k) decision of Substantially Equivalent on March 15, 2011, 85 days after the submission was received.
What is the product code of K103700?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.