K934385 is an FDA 510(k) clearance for the MINIPACK 3100/3000 MODIFICATION. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 10, 1994, 335 days after receiving the submission on September 9, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K934385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1993 |
| Decision Date | August 10, 1994 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |