The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Vasera Model Vs-1500.
| Device ID | K112521 |
| 510k Number | K112521 |
| Device Name: | FUKUDA DENSHI VASERA MODEL VS-1500 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| Subsequent Product Code | DQC |
| Subsequent Product Code | JOO |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612912498 | K112521 | 000 |
| 04538612908101 | K112521 | 000 |
| 04538612908095 | K112521 | 000 |
| 04538612908088 | K112521 | 000 |
| 04538612908071 | K112521 | 000 |
| 04538612908064 | K112521 | 000 |
| 04538612311499 | K112521 | 000 |
| 04538612310942 | K112521 | 000 |
| 04538612310935 | K112521 | 000 |
| 04538612310836 | K112521 | 000 |
| 04538612912658 | K112521 | 000 |
| 04538612912269 | K112521 | 000 |
| 04538612312243 | K112521 | 000 |
| 04538612023194 | K112521 | 000 |
| 04538612908118 | K112521 | 000 |
| 04538612908125 | K112521 | 000 |
| 04538612908132 | K112521 | 000 |
| 04538612912481 | K112521 | 000 |
| 04538612912474 | K112521 | 000 |
| 04538612912467 | K112521 | 000 |
| 04538612912450 | K112521 | 000 |
| 04538612912443 | K112521 | 000 |
| 04538612912320 | K112521 | 000 |
| 04538612912306 | K112521 | 000 |
| 04538612912283 | K112521 | 000 |
| 04538612910609 | K112521 | 000 |
| 04538612908170 | K112521 | 000 |
| 04538612908163 | K112521 | 000 |
| 04538612908156 | K112521 | 000 |
| 04538612908149 | K112521 | 000 |
| 04538612912351 | K112521 | 000 |