Submission Details
| 510(k) Number | K932572 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 1993 |
| Decision Date | November 16, 1993 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
K932572 is an FDA 510(k) clearance for the DIGITAL BABY SCALE MODEL BLB-12, a Scale, Patient (Class I — General Controls, product code FRW), submitted by Tanita Corp. of America (Skokie, US). The FDA issued a Cleared decision on November 16, 1993, 173 days after receiving the submission on May 27, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K932572 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 1993 |
| Decision Date | November 16, 1993 |
| Days to Decision | 173 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 |