The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Scale-tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006c & 20009, Model N661wc.
| Device ID | K012229 |
| 510k Number | K012229 |
| Device Name: | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC |
| Classification | Warmer, Infant Radiant |
| Applicant | NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Contact | Don Pelletier |
| Correspondent | Don Pelletier NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-09-10 |