The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Fcp-2155 Multi Channel, Interpretive Electrocardiograph.
| Device ID | K971440 |
| 510k Number | K971440 |
| Device Name: | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| 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 | LOS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-18 |
| Decision Date | 1997-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612910586 | K971440 | 000 |
| 04538612021749 | K971440 | 000 |
| 04538612906879 | K971440 | 000 |
| 04538612034992 | K971440 | 000 |
| 04538612913877 | K971440 | 000 |
| 04538612914126 | K971440 | 000 |
| 04538612914133 | K971440 | 000 |
| 04538612905209 | K971440 | 000 |
| 04538612905216 | K971440 | 000 |
| 04538612910531 | K971440 | 000 |
| 04538612021442 | K971440 | 000 |