The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Bci 3401 Handheld Pulse Oximeter.
| Device ID | K980714 |
| 510k Number | K980714 |
| Device Name: | BCI 3401 HANDHELD PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Donald J Alexander |
| Correspondent | Donald J Alexander BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-24 |
| Decision Date | 1998-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720011902 | K980714 | 000 |
| 00026072011904 | K980714 | 000 |