K010130 is an FDA 510(k) clearance for the POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103. This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).
Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on February 7, 2001, 22 days after receiving the submission on January 16, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K010130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2001 |
| Decision Date | February 07, 2001 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFX — System, Gastrointestinal Motility (electrical) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |