K023616 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES). This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on November 4, 2002, 6 days after receiving the submission on October 29, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K023616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2002 |
| Decision Date | November 04, 2002 |
| Days to Decision | 6 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |