Submission Details
| 510(k) Number | K072598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 14, 2007 |
| Decision Date | April 14, 2008 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
IRSG I-MOVER FOR BEDS
Apr 2008
Decision
213d
Days
Class 2
Risk
About This 510(k) Submission
K072598 is an FDA 510(k) clearance for the IRSG I-MOVER FOR BEDS, a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by International Retail Services Group, LLC (Woodinville, US). The FDA issued a Cleared decision on April 14, 2008, 213 days after receiving the submission on September 14, 2007. 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
International Retail Services Group, LLC
Woodinville, WA · US
KAREN M RUSSELL
1 submissions
1 cleared
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