K912929 is an FDA 510(k) clearance for the DASH IV. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).
Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on August 13, 1991, 39 days after receiving the submission on July 5, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.
| 510(k) Number | K912929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1991 |
| Decision Date | August 13, 1991 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSF — Recorder, Paper Chart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2810 |