The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Ds-5100e Portable Patient Monitor.
| Device ID | K971131 |
| 510k Number | K971131 |
| Device Name: | FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-10-03 |
| Summary: | summary |