Bci Intl., Inc.
Waukesha, WI, US
Bci Intl., Inc. appears in FDA device records in Waukesha, WI. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Bci Intl., Inc. between 1994 and 1999. The busiest year on record is 1995, with 4. The most recent is 1999, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991410 | 3402 HANDHELD PULSE OXIMETER | DQA | Substantially Equivalent | |
| K991086 | CAPNOCHECK II, MODEL 8400 | CCK | Substantially Equivalent | |
| K984618 | BCI MINI-TORR PLUS, MODEL 6004 | DXN | Substantially Equivalent | |
| K983796 | 6004 NIBP MONITOR WITH TEMPERATURE | DXN | Substantially Equivalent | |
| K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | MHX | Substantially Equivalent | |
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | DQA | Substantially Equivalent | |
| K980714 | BCI 3401 HANDHELD PULSE OXIMETER | DQA | Substantially Equivalent | |
| K974697 | REUSABLE FINGER SENSOR 3444 | DQH | Substantially Equivalent | |
| K970801 | BCI MODEL 6004 NIBP MONITOR (6004) | DXN | Substantially Equivalent | |
| K970209 | CAPNOCHECK PLUS | CCK | Substantially Equivalent | |
| K963496 | OXI TEMP | DQA | Substantially Equivalent | |
| K962156 | 3304 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K960058 | OXITEMP, 3301T SA | DQA | Substantially Equivalent | |
| K953415 | 6200 VITAL SIGNS MONITOR | DPS | Substantially Equivalent | |
| K953126 | OXILINK (SMALL, MEDIUM, LARGE) | DQA | Substantially Equivalent | |
| K945754 | NEWOX2 | DQA | Substantially Equivalent | |
| K946185 | 3301T OXITEMP | DQA | Substantially Equivalent | |
| K941971 | 9100 MUTIGAS MONITOR | CCK | Substantially Equivalent | |
| K943404 | 3301 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K941289 | PULSE OXIMETER | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain