K170305 is an FDA 510(k) clearance for the Spinal Manometer NRFit. This device is classified as a Manometer, Spinal-fluid (Class II - Special Controls, product code FMJ).
Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 25, 2017, 175 days after receiving the submission on January 31, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2500.
| 510(k) Number | K170305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2017 |
| Decision Date | July 25, 2017 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMJ — Manometer, Spinal-fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2500 |