Submission Details
| 510(k) Number | K964873 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 1996 |
| Decision Date | July 03, 1997 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
SILKAIR LOW AIRLOSS THERAPY
Jul 1997
Decision
210d
Days
Class 2
Risk
About This 510(k) Submission
K964873 is an FDA 510(k) clearance for the SILKAIR LOW AIRLOSS THERAPY, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on July 3, 1997, 210 days after receiving the submission on December 5, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.
Device Classification
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5170 |
Manufacturer
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