FDA 510(k) · Sunrise Medical Hhg
K012437: DEVILBISS SLEEP RECORDER MODEL # RM60 (Sunrise Medical Hhg, Inc.)
Sunrise Medical Hhg, Inc. received FDA 510(k) K012437 for DEVILBISS SLEEP RECORDER MODEL # RM60, with a decision date of Jul 16, 2002 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K012437 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sunrise Medical Hhg, Inc. |
| Device name | DEVILBISS SLEEP RECORDER MODEL # RM60 |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jul 31, 2001 |
| Decision date | Jul 16, 2002 |
| 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
Statement
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.
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.