Trip NGS & Sigmoid Catheter Phi Slide Calculator
FDA 510(k) K955018 · Instrumentarium Corp.
510(k) numberK955018
Submission
- Device name
- Trip NGS & Sigmoid Catheter Phi Slide Calculator
- Applicant
- Instrumentarium Corp.
Boston, MA, US - Received
- November 2, 1995
- Decision date
- January 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFT – Electrode, Ph, Stomach
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1400
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
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| K013951 | Sandhill Scientific Pediatec PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 02/28/2002SE |
| K002028 | Bravo PH Monitoring SystemFFT · Traditional | Endonetics, Inc. | 09/29/2000SE |
| K961346 | PH Analysis ModuleFFT · Traditional | Synectics-Dantec | 01/29/1997SE |
| K950087 | Lot 440FFT · Traditional | Medical Instruments Corporation Mic AG | 02/06/1996SE |
| K945069 | Flexilog 2000FFT · Traditional | Oakfield Instruments, Ltd. | 06/13/1995SE |
| K920849 | Trip Cic CatheterFFT · Traditional | Tonometrics, Inc. | 03/17/1995SE |
| K934434 | Cyberrx Model 7200FFT · Traditional | Cybermed Control Systems, Inc. | 01/24/1995SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | Synectics-Dantec | 09/30/1994SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 09/28/1994SE |
More from Sandhill Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K001439 | Orthoceph OC100 DMUH · Traditional | 06/22/2000SE |
| K992385 | Orthopantomograph OP100DMUH · Traditional | 09/28/1999SE |
| K981641 | Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and…IZH · Traditional | 07/17/1998SE |
| K962638 | Tonocap, TC-200 and Accessory CathetersCCK · Traditional | 04/04/1997SE |
| K961441 | Tonometered Slaine Blood Gas ControlJJS · Traditional | 04/30/1996SE |
| K934478 | Alpha StereoIZH · Traditional | 01/31/1995SE |
| K923433 | AS/3 Anaesthesia Monitoring System Airway ModuleCBQ · Traditional | 07/22/1993SE |
| K930338 | Orthoceph OC100EHD · Traditional | 04/27/1993SE |
Questions and answers
When was Trip NGS & Sigmoid Catheter Phi Slide Calculator cleared by the FDA?
Trip NGS & Sigmoid Catheter Phi Slide Calculator (K955018) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 89 days after the submission was received.
What is the product code of K955018?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.