The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 9100 Mutigas Monitor.
| Device ID | K941971 |
| 510k Number | K941971 |
| Device Name: | 9100 MUTIGAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Scott Pease |
| Correspondent | Scott Pease 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 | 1994-04-22 |
| Decision Date | 1994-11-21 |