The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Advisor, Model 9200.
| Device ID | K030407 |
| 510k Number | K030407 |
| Device Name: | ADVISOR, MODEL 9200 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BCI, INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander BCI, INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-07 |
| Decision Date | 2003-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517062667 | K030407 | 000 |
| 35019517054143 | K030407 | 000 |
| 15019517057713 | K030407 | 000 |
| 15019517053838 | K030407 | 000 |
| 15019517053821 | K030407 | 000 |