Innersense Esophageal Temperature/Feeding Tube
FDA 510(k) K120815 · Philips Medical Systems
510(k) numberK120815
Submission
- Device name
- Innersense Esophageal Temperature/Feeding Tube
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- March 19, 2012
- Decision date
- March 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPD – Tube, Feeding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
| K100526 | Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional | Kentec Medical, Inc. | 04/22/2010SE |
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Questions and answers
When was Innersense Esophageal Temperature/Feeding Tube cleared by the FDA?
Innersense Esophageal Temperature/Feeding Tube (K120815) received a 510(k) decision of Substantially Equivalent on March 6, 2013, 352 days after the submission was received.
What is the product code of K120815?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.