K893398 is an FDA 510(k) clearance for the CENTRALITE BACKPOINTER. This device is classified as a Monitor, Patient Position, Light-beam (Class I - General Controls, product code IWE).
Submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 17, 1989, 108 days after receiving the submission on May 1, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5780.
| 510(k) Number | K893398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1989 |
| Decision Date | August 17, 1989 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWE — Monitor, Patient Position, Light-beam |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.5780 |