The following data is part of a premarket notification filed by U.s. Medical Corp. with the FDA for U. S. Medical Ps-3500 Warmer/incubator Scale.
| Device ID | K934677 |
| 510k Number | K934677 |
| Device Name: | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE |
| Classification | Warmer, Infant Radiant |
| Applicant | U.S. MEDICAL CORP. 12 SCOVIL RD. Higgaum, CT 06441 |
| Contact | Bruce E Dodson |
| Correspondent | Bruce E Dodson U.S. MEDICAL CORP. 12 SCOVIL RD. Higgaum, CT 06441 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-28 |
| Decision Date | 1994-07-05 |