K841534 is an FDA 510(k) clearance for the ACME DIGITAL INFANT SCALE-30. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).
Submitted by Acme Medical Scale Co. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 45 days after receiving the submission on April 16, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K841534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1984 |
| Decision Date | May 31, 1984 |
| Days to Decision | 45 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 |