The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 3402 Handheld Pulse Oximeter.
| Device ID | K991410 |
| 510k Number | K991410 |
| Device Name: | 3402 HANDHELD PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-22 |
| Decision Date | 1999-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517043051 | K991410 | 000 |