The following data is part of a premarket notification filed by Scale-tronix, Inc. with the FDA for 4002 Infant Scale For Incubators And Warmers.
| Device ID | K935609 |
| 510k Number | K935609 |
| Device Name: | 4002 INFANT SCALE FOR INCUBATORS AND WARMERS |
| Classification | Warmer, Infant Radiant |
| Applicant | SCALE-TRONIX, INC. P.O. BOX 15 Wheaton, IL 60189 |
| Contact | E. A. Stanis |
| Correspondent | E. A. Stanis SCALE-TRONIX, INC. P.O. BOX 15 Wheaton, IL 60189 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-19 |
| Decision Date | 1994-07-01 |