The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss Sleep Recorder Model # Rm60.
| Device ID | K012437 |
| 510k Number | K012437 |
| Device Name: | DEVILBISS SLEEP RECORDER MODEL # RM60 |
| Classification | Ventilatory Effort Recorder |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Jim Froehlich |
| Correspondent | Jim Froehlich SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-31 |
| Decision Date | 2002-07-16 |
| Summary: | summary |