Acem
FDA 510(k) K111013 · Sandhill Scientific, Inc.
510(k) numberK111013
Submission
- Device name
- Acem
- Applicant
- Sandhill Scientific, Inc.
Boulder, CO, US - Received
- April 11, 2011
- Decision date
- December 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFZ – Cord, Electric, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFZ
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| K990441 | Insight Sphincter of Oddi Manometry Module, Model S981300FFX · Traditional | 05/12/1999SE |
| K984444 | Insight Gastrointestinal Motility System, Model S980000FFX · Special | 01/11/1999SE |
| K961056 | Bioview Model S960000KLA · Traditional | 06/06/1996SE |
| K942247 | Small Bowel Analysis SoftwareFFX · Traditional | 04/09/1996SE |
| K941801 | AnalgraphKLA · Traditional | 09/08/1995SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | 09/28/1994SE |
| K926218 | Eisman-Tries Mep (Multiple Electrode Probe)HIR · Traditional | 08/26/1994SE |
Questions and answers
When was Acem cleared by the FDA?
Acem (K111013) received a 510(k) decision of Substantially Equivalent on December 19, 2011, 252 days after the submission was received.
What is the product code of K111013?
The FDA product code is FFZ – Cord, Electric, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.