FDA 510(k) · Bio-Logic Systems
K962103: BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER (Bio-Logic Systems Corp.)
Bio-Logic Systems Corp. received FDA 510(k) K962103 for BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER, with a decision date of Aug 22, 1996 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K962103 |
|---|---|
| Pathway | 510(k) |
| Applicant | Bio-Logic Systems Corp. |
| Device name | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | May 30, 1996 |
| Decision date | Aug 22, 1996 |
| 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 (no summary PDF was processed). 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.
Later records that cite K962103
- K012437 DEVILBISS SLEEP RECORDER MODEL # RM60 (Sunrise Medical Hhg, Jul 16, 2002, MNR)
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 MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Other. These are heuristics, not FDA fields.