Submission Details
| 510(k) Number | K974296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1997 |
| Decision Date | January 06, 1998 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K974296 is an FDA 510(k) clearance for the MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED, a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on January 6, 1998, 50 days after receiving the submission on November 17, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K974296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1997 |
| Decision Date | January 06, 1998 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FNL — Bed, Ac-powered Adjustable Hospital |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5100 |