The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-8100n/8100m Patient Monitor.
| Device ID | K134046 |
| 510k Number | K134046 |
| Device Name: | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR |
| 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 | Doug Blakely |
| Correspondent | Doug Blakely 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2015-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612910326 | K134046 | 000 |
| 04538612910968 | K134046 | 000 |
| 04538612910494 | K134046 | 000 |
| 04538612910487 | K134046 | 000 |
| 04538612910470 | K134046 | 000 |
| 04538612910357 | K134046 | 000 |
| 04538612910333 | K134046 | 000 |
| 04538612910074 | K134046 | 000 |
| 04538612909382 | K134046 | 000 |
| 04538612054167 | K134046 | 000 |
| 04538612911200 | K134046 | 000 |
| 04538612017100 | K134046 | 000 |
| 04538612910302 | K134046 | 000 |
| 04538612909962 | K134046 | 000 |
| 04538612910852 | K134046 | 000 |
| 04538612910821 | K134046 | 000 |
| 04538612910814 | K134046 | 000 |
| 04538612910807 | K134046 | 000 |
| 04538612910791 | K134046 | 000 |
| 04538612909955 | K134046 | 000 |
| 04538612227561 | K134046 | 000 |
| 04538612911002 | K134046 | 000 |