The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for 645ob Sector/linear Ultrasound Scanner.
| Device ID | K861931 |
| 510k Number | K861931 |
| Device Name: | 645OB SECTOR/LINEAR ULTRASOUND SCANNER |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Joseph P Lenzen |
| Correspondent | Joseph P Lenzen GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-07-31 |