The following data is part of a premarket notification filed by Futrex, Inc. with the FDA for Healthguard-15.
| Device ID | K143108 |
| 510k Number | K143108 |
| Device Name: | HealthGuard-15 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FUTREX, INC. 130 WESTERN MARYLAND PKWY. Hagerstown, MD 21740 |
| Contact | Carole Rosenthal |
| Correspondent | Carole Rosenthal FUTREX, INC. 130 WESTERN MARYLAND PKWY. Hagerstown, MD 21740 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010558515 | K143108 | 000 |
| 00860010558508 | K143108 | 000 |