K790418 is an FDA 510(k) clearance for the MODEL 8100 PRE-FILLED INTRAUTERINE. This device is classified as a Monitor, Pressure, Intrauterine (Class II - Special Controls, product code KXO).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979, 21 days after receiving the submission on February 28, 1979.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K790418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1979 |
| Decision Date | March 21, 1979 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | KXO - Monitor, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |