K071168 is an FDA 510(k) clearance for the THE PORTABLE ANSISCOPE. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Dyansys, Inc. (Orinda, US). The FDA issued a Cleared decision on August 31, 2007, 126 days after receiving the submission on April 27, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K071168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |