The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Mammographic Kvp Meter Model 232.
| Device ID | K873836 |
| 510k Number | K873836 |
| Device Name: | MAMMOGRAPHIC KVP METER MODEL 232 |
| Classification | System, X-ray, Mammographic |
| Applicant | RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
| Contact | Joel R Schenck |
| Correspondent | Joel R Schenck RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-21 |
| Decision Date | 1987-10-16 |