The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Capnocheck Ii, Model 8400.
| Device ID | K991086 |
| 510k Number | K991086 |
| Device Name: | CAPNOCHECK II, MODEL 8400 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517053665 | K991086 | 000 |
| 35019517053641 | K991086 | 000 |
| 35019517053627 | K991086 | 000 |
| 35019315002865 | K991086 | 000 |
| 10610586036781 | K991086 | 000 |
| 10610586036354 | K991086 | 000 |
| 10610586038273 | K991086 | 000 |