The following data is part of a premarket notification filed by Scale-tronix, Inc. with the FDA for Scale-tronix Incubator Scale Model:4050/modified.
| Device ID | K904286 |
| 510k Number | K904286 |
| Device Name: | SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED |
| Classification | Scale, Patient |
| 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 | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-01 |