The following data is part of a premarket notification filed by Continuity Health Solutions with the FDA for Ally Platform System.
| Device ID | K093895 |
| 510k Number | K093895 |
| Device Name: | ALLY PLATFORM SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CONTINUITY HEALTH SOLUTIONS 850 NORTH 25TH STREET Ozark, MO 65721 |
| Contact | Brian Poteet |
| Correspondent | Brian Poteet CONTINUITY HEALTH SOLUTIONS 850 NORTH 25TH STREET Ozark, MO 65721 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-05-20 |
| Summary: | summary |