The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Hg-301.
| Device ID | K921454 |
| 510k Number | K921454 |
| Device Name: | FUKUDA DENSHI MODEL HG-301 |
| Classification | Oximeter |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | Robert Steurer |
| Correspondent | Robert Steurer FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-26 |
| Decision Date | 1994-04-01 |