The following data is part of a premarket notification filed by Medical Equipment Resources with the FDA for Mer Multiplane Vaginal Probe (mvp).
| Device ID | K901142 |
| 510k Number | K901142 |
| Device Name: | MER MULTIPLANE VAGINAL PROBE (MVP) |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | MEDICAL EQUIPMENT RESOURCES 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook MEDICAL EQUIPMENT RESOURCES 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-08-22 |