K945385 is an FDA 510(k) clearance for the VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 31, 1995, 89 days after receiving the submission on November 3, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K945385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1994 |
| Decision Date | January 31, 1995 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |