K800805 is an FDA 510(k) clearance for the LINEAR ARRAY SCANNER. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 102 days after receiving the submission on April 10, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K800805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1980 |
| Decision Date | July 21, 1980 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |