K842261 is an FDA 510(k) clearance for the OB ULTRASOUND LINEAR SCANNER 630. This device is classified as a Imager, Ultrasonic Obstetric-gynecologic (Class II - Special Controls, product code HEM).
Submitted by Ge Medical Systems Information Technologies (Walker, US). The FDA issued a Cleared decision on September 19, 1984, 104 days after receiving the submission on June 7, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2225.
| 510(k) Number | K842261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1984 |
| Decision Date | September 19, 1984 |
| Days to Decision | 104 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 |