BCI 3180 PULSE OXIMETER
FDA 510(k) clearance K020350 · decided 2002-04-30
Clearance details
- K-number
- K020350
- Device name
- BCI 3180 PULSE OXIMETER
- Applicant
- Bci, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-04
- Decision date
- 2002-04-30
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bci
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Mai recall (Z-0919-2010) | Smiths Medical PM, Inc. | 2010-03-02 |
| BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, recall (Z-1619-2008) | Smiths Medical PM, Inc. | 2008-08-15 |