The following data is part of a premarket notification filed by Scale-tronix, Inc. with the FDA for Scale-tronix Incubator Scale Model:4050.
Device ID | K902260 |
510k Number | K902260 |
Device Name: | SCALE-TRONIX INCUBATOR SCALE MODEL:4050 |
Classification | Scale, Patient |
Applicant | SCALE-TRONIX, INC. P.O. BOX 15 Wheaton, IL 60189 |
Contact | Stanis |
Correspondent | 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 | 1990-05-21 |
Decision Date | 1990-08-14 |