The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Capnocheck Plus.
| Device ID | K970209 |
| 510k Number | K970209 |
| Device Name: | CAPNOCHECK PLUS |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517062254 | K970209 | 000 |
| 15019517053739 | K970209 | 000 |
| 15019517053760 | K970209 | 000 |
| 15019517053777 | K970209 | 000 |
| 15019517053784 | K970209 | 000 |
| 15019517053807 | K970209 | 000 |
| 15019517053814 | K970209 | 000 |
| 15019517058253 | K970209 | 000 |
| 15019517058260 | K970209 | 000 |
| 15019517058277 | K970209 | 000 |
| 35019517053672 | K970209 | 000 |
| 35019517053795 | K970209 | 000 |
| 10610586038389 | K970209 | 000 |