The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-5000 Central Telemetry System.
| Device ID | K033711 |
| 510k Number | K033711 |
| Device Name: | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Larry D Walker |
| Correspondent | Larry D Walker FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612903212 | K033711 | 000 |
| 04538612901836 | K033711 | 000 |
| 04538612901829 | K033711 | 000 |