Submission Details
| 510(k) Number | K143068 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 2014 |
| Decision Date | January 14, 2015 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Medical Monofilament Sensory Screening Toool
Jan 2015
Decision
82d
Days
Class 1
Risk
About This 510(k) Submission
K143068 is an FDA 510(k) clearance for the Medical Monofilament Sensory Screening Toool, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Medical Monofilament Manufacturing (Plymouth, US). The FDA issued a Cleared decision on January 14, 2015, 82 days after receiving the submission on October 24, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.
Device Classification
| Product Code | GXB — Esthesiometer |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 882.1500 |
Manufacturer
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