FDA 510(k) · Widemed
K070326: NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM (Widemed, Ltd.)
Widemed, Ltd. received FDA 510(k) K070326 for NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM, with a decision date of May 5, 2007 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K070326 |
|---|---|
| Pathway | 510(k) |
| Applicant | Widemed, Ltd. |
| Device name | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Feb 5, 2007 |
| Decision date | May 5, 2007 |
| 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
The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders. The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device. Physiological data includes: ECG, SPO2, EtCO2 and Impedance respiration This system is to be used under the supervision of a physician. 5.14
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K070326
- K073269 HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM (Hypnocore, Apr 18, 2008, 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 Sleep apnea, sensor Other. These are heuristics, not FDA fields.