Submission Details
| 510(k) Number | K191436 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 30, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
Saalio
Oct 2019
Decision
141d
Days
Class 2
Risk
About This 510(k) Submission
K191436 is an FDA 510(k) clearance for the Saalio, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Saalmann Medical GmbH & Co. KG (Bad Oeynhausen, DE). The FDA issued a Cleared decision on October 18, 2019, 141 days after receiving the submission on May 30, 2019. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.
Device Classification
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5525 |
Manufacturer
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