K883960 is an FDA 510(k) clearance for the GIPHY MONITOR. This device is classified as a Electrode, Ph, Stomach (Class I - General Controls, product code FFT).
Submitted by Vascular Technology Incorporated (Chelmsford, US). The FDA issued a Cleared decision on October 4, 1989, 379 days after receiving the submission on September 20, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K883960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1988 |
| Decision Date | October 04, 1989 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1400 |