K910029 is an FDA 510(k) clearance for the PATIENT CARE MANAGEMENT SYSTEM MODIFICATION. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on January 31, 1991, 28 days after receiving the submission on January 3, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K910029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1991 |
| Decision Date | January 31, 1991 |
| Days to Decision | 28 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 |