K861931 is an FDA 510(k) clearance for the 645OB SECTOR/LINEAR ULTRASOUND SCANNER. This device is classified as a Imager, Ultrasonic Obstetric-gynecologic (Class II - Special Controls, product code HEM).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on July 31, 1986, 72 days after receiving the submission on May 20, 1986.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2225.
| 510(k) Number | K861931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 20, 1986 |
| Decision Date | July 31, 1986 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HEM - Imager, Ultrasonic Obstetric-gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2225 |