The following data is part of a premarket notification filed by Sanitas, Inc. with the FDA for Wellaho Personalized Outpatient Management System.
| Device ID | K123671 |
| 510k Number | K123671 |
| Device Name: | WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92127 |
| Contact | Alan Donald |
| Correspondent | Alan Donald SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92127 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-29 |
| Decision Date | 2013-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860508000311 | K123671 | 000 |