Submission Details
| 510(k) Number | K952447 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 25, 1995 |
| Decision Date | November 22, 1995 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
Nov 1995
Decision
181d
Days
Class 2
Risk
About This 510(k) Submission
K952447 is an FDA 510(k) clearance for the HILL-ROM AMBULATORY CARE PROCEDURAL 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 November 22, 1995, 181 days after receiving the submission on May 25, 1995. 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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