The following data is part of a premarket notification filed by Grass Technologies, An Astro-med, Inc. Product Gro with the FDA for De48-plus.
| Device ID | K123915 |
| 510k Number | K123915 |
| Device Name: | DE48-PLUS |
| Classification | Electrode, Cutaneous |
| Applicant | GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO 53 AIRPORT PARK DRIVE Rockland, MA 02370 |
| Contact | Phillip Soares |
| Correspondent | Phillip Soares GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO 53 AIRPORT PARK DRIVE Rockland, MA 02370 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-04-24 |
| Summary: | summary |