The following data is part of a premarket notification filed by Medical Instrumentation & Diagnostics Corp.(midco) with the FDA for Computer Assisted Stereotactic Surgery -- Modified.
| Device ID | K921740 |
| 510k Number | K921740 |
| Device Name: | COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Contact | T. L Hardy |
| Correspondent | T. L Hardy MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) 806 SAGEBRUSH COURT SOUTHEAST Albuquerque, NM 87123 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1993-04-07 |