Vital Signs Monitor
FDA 510(k) K112465 · Advanced Instruments, Inc.
510(k) numberK112465
Submission
- Device name
- Vital Signs Monitor
- Applicant
- Advanced Instruments, Inc.
Hialeah, FL, US - Received
- August 26, 2011
- Decision date
- September 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K962056 | Advanced Micro-Osmometer Model 3300JJM · Traditional | 07/11/1996SE |
| K930526 | Intermittent Compression System Model 5000JOW · Traditional | 11/18/1993SE |
| K925970 | Model 3D3 OsmometerJJM · Traditional | 07/09/1993SE |
| K911092 | Osmometer Model 2400JJM · Traditional | 05/22/1991SE |
| K873642 | Osmometer Model 110JJM · Traditional | 10/20/1987SE |
| K863516 | Electronic Metal Locator Model MD-1 · Traditional | 09/30/1986SE |
| K842784 | CeregrotracGWQ · Traditional | 01/10/1985SE |
Questions and answers
When was Vital Signs Monitor cleared by the FDA?
Vital Signs Monitor (K112465) received a 510(k) decision of Substantially Equivalent on September 14, 2011, 19 days after the submission was received.
What is the product code of K112465?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.