Submission Details
| 510(k) Number | K943587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1994 |
| Decision Date | September 22, 1994 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
K943587 is an FDA 510(k) clearance for the ADVANCED IN-BED WEIGH SYSTEM, a Scale, Patient (Class I — General Controls, product code FRW), submitted by Future Systems, Inc. (Chicago, US). The FDA issued a Cleared decision on September 22, 1994, 62 days after receiving the submission on July 22, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K943587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1994 |
| Decision Date | September 22, 1994 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRW — Scale, Patient |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.2720 |