FDA 510(k) · Hypnocore
K073269: HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM (Hypnocore, Ltd.)
Hypnocore, Ltd. received FDA 510(k) K073269 for HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM, with a decision date of Apr 18, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K073269 |
|---|---|
| Pathway | 510(k) |
| Applicant | Hypnocore, Ltd. |
| Device name | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Nov 21, 2007 |
| Decision date | Apr 18, 2008 |
| 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
510(k) Number (ifknown): j( L ~3 ? Device Name: HC1000P Sleep Diagqnosis Software System Indications For Use: HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid inthe diagnosis of sleep and sleep related breathing disorders. Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) /44k2 (Division Sign-Off)
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.
- K070326 NOGA AUTOMATED SLEEP STUDY SCORING AND… (Widemed)
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.