K855045 is an FDA 510(k) clearance for the MODEL 535 NEO-TRAK RECORDER. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on May 16, 1986, 150 days after receiving the submission on December 17, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.
| 510(k) Number | K855045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1985 |
| Decision Date | May 16, 1986 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DSF - Recorder, Paper Chart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2810 |