CAPNOCHECK
Analyzer, Gas, Carbon-dioxide, Gaseous-phase
BCI, INC.
The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Capnocheck.
Pre-market Notification Details
| Device ID | K941982 |
| 510k Number | K941982 |
| Device Name: | CAPNOCHECK |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BCI, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 -1199 |
| Contact | Scott J Pease |
| Correspondent | Scott J Pease BCI, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 -1199 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-10-17 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517053740 | K941982 | 000 |
| 35019517053726 | K941982 | 000 |
| 30610586038444 | K941982 | 000 |
| 30610586038345 | K941982 | 000 |
| 10610586042935 | K941982 | 000 |
Trademark Results [CAPNOCHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPNOCHECK 74051455 1692750 Live/Registered |
Biochem International, Inc. 1990-04-23 |
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