The following data is part of a premarket notification filed by Phd Medical with the FDA for Nposes (nocturnal Pulse Oximetry Study Expert System), Model Nposes-100.
| Device ID | K060616 |
| 510k Number | K060616 |
| Device Name: | NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 |
| Classification | Oximeter |
| Applicant | PHD MEDICAL 4 INNOVATION DRIVE Dundas, On, CA L9h 7p3 |
| Contact | Nancy Ruth |
| Correspondent | Nancy Ruth PHD MEDICAL 4 INNOVATION DRIVE Dundas, On, CA L9h 7p3 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-08 |
| Decision Date | 2006-06-29 |
| Summary: | summary |