K895449 is an FDA 510(k) clearance for the ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM. This device is classified as a Transducer, Ultrasonic, Obstetric (Class II - Special Controls, product code HGL).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on March 5, 1990, 194 days after receiving the submission on August 23, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2960.
| 510(k) Number | K895449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1989 |
| Decision Date | March 05, 1990 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HGL - Transducer, Ultrasonic, Obstetric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2960 |