Submission Details
| 510(k) Number | K961437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 15, 1996 |
| Decision Date | June 03, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
WHEELED STRETCHER
Jun 1996
Decision
49d
Days
Class 2
Risk
About This 510(k) Submission
K961437 is an FDA 510(k) clearance for the WHEELED STRETCHER, a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on June 3, 1996, 49 days after receiving the submission on April 15, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6910.
Device Classification
| Product Code | FPO — Stretcher, Wheeled |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6910 |
Manufacturer
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