K910583 is an FDA 510(k) clearance for the U.S. MEDICAL PS-3000 NEONATAL SCALE. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).
Submitted by U.S. Medical Corp. (Cheshire, US). The FDA issued a Cleared decision on March 21, 1991, 38 days after receiving the submission on February 11, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K910583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1991 |
| Decision Date | March 21, 1991 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRW — Scale, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2720 |