The following data is part of a premarket notification filed by Columbia Scientific, Inc. with the FDA for Csi/mpr Or Csi/mpr Plus.
| Device ID | K861852 |
| 510k Number | K861852 |
| Device Name: | CSI/MPR OR CSI/MPR PLUS |
| Classification | System, Image Processing, Radiological |
| Applicant | COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Contact | Charles D Stockham |
| Correspondent | Charles D Stockham COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-14 |
| Decision Date | 1986-10-08 |