The following data is part of a premarket notification filed by Medical Equipment Resources with the FDA for Mer Multiplane Rectal Probe (mrp).
| Device ID | K901033 |
| 510k Number | K901033 |
| Device Name: | MER MULTIPLANE RECTAL PROBE (MRP) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-08-22 |