The following data is part of a premarket notification filed by Vitaltrends Technology, Inc. with the FDA for Vsi 1000.
| Device ID | K912921 |
| 510k Number | K912921 |
| Device Name: | VSI 1000 |
| Classification | Warmer, Infant Radiant |
| Applicant | VITALTRENDS TECHNOLOGY, INC. 45 WEST ST. SUITE 2 North Attleboro, MA 02703 |
| Contact | George M Baskinger |
| Correspondent | George M Baskinger VITALTRENDS TECHNOLOGY, INC. 45 WEST ST. SUITE 2 North Attleboro, MA 02703 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1992-10-30 |