The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Hg-500, Pulse Oximeter Module.
| Device ID | K013273 |
| 510k Number | K013273 |
| Device Name: | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE |
| Classification | Oximeter |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Larry Walker |
| Correspondent | Larry Walker FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-12-20 |
| Summary: | summary |