The following data is part of a premarket notification filed by U.s. Medical Corp. with the FDA for U.s. Medical Ps-3000 Neonatal Scale.
| Device ID | K910583 |
| 510k Number | K910583 |
| Device Name: | U.S. MEDICAL PS-3000 NEONATAL SCALE |
| Classification | Scale, Patient |
| Applicant | U.S. MEDICAL CORP. 408 HIGHLAND AVENLUE P.O. BOX 580 Cheshire, CT 06410 |
| Contact | Bruce E Dodson |
| Correspondent | Bruce E Dodson U.S. MEDICAL CORP. 408 HIGHLAND AVENLUE P.O. BOX 580 Cheshire, CT 06410 |
| Product Code | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-11 |
| Decision Date | 1991-03-21 |