The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Hc-300 End Tidal Co2 Module.
| Device ID | K950044 |
| 510k Number | K950044 |
| Device Name: | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-05 |
| Decision Date | 1995-09-15 |