K023749 is an FDA 510(k) clearance for the THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B). This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on November 19, 2002, 11 days after receiving the submission on November 8, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K023749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2002 |
| Decision Date | November 19, 2002 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |