K874138 is an FDA 510(k) clearance for the ACCUCOM 2. This device is classified as a Probe, Blood-flow, Extravascular (Class II - Special Controls, product code DPT).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on June 1, 1988, 232 days after receiving the submission on October 13, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K874138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1987 |
| Decision Date | June 01, 1988 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DPT - Probe, Blood-flow, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2120 |