The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Radioisotope Calibrator (crco-22nb).
| Device ID | K761145 |
| 510k Number | K761145 |
| Device Name: | RADIOISOTOPE CALIBRATOR (CRCO-22NB) |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-26 |
| Decision Date | 1976-12-16 |