The following data is part of a premarket notification filed by Laboratory Equipment Corp. with the FDA for Labsonics Mamm-o-mate Model No. 918084-1, Modified.
| Device ID | K905522 |
| 510k Number | K905522 |
| Device Name: | LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | LABORATORY EQUIPMENT CORP. P.O. BOX 787 Mooresville, IN 46158 |
| Contact | Michael B Stayton |
| Correspondent | Michael B Stayton LABORATORY EQUIPMENT CORP. P.O. BOX 787 Mooresville, IN 46158 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1991-06-11 |