FDA 510(k) · BCI
K011156: BCI 3403 SLEEP SCREENING PULSE OXIMETER (Bci, Inc.)
Bci, Inc. received FDA 510(k) K011156 for BCI 3403 SLEEP SCREENING PULSE OXIMETER, with a decision date of Jun 14, 2001 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K011156 |
|---|---|
| Pathway | 510(k) |
| Applicant | Bci, Inc. |
| Device name | BCI 3403 SLEEP SCREENING PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 16, 2001 |
| Decision date | Jun 14, 2001 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record because FDA's summary PDF was not available at the usual address. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.