510(k) K170305
K170305 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "Spinal Manometer NRFit; Spinal Manometer LUER". The FDA issued a decision of Substantially Equivalent on July 25, 2017. The device falls under product code FMJ (Manometer, Spinal-Fluid), a Class II device regulated under 21 CFR 880.2500. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2017
- Date Received
- January 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manometer, Spinal-Fluid
- Device Class
- Class II
- Regulation Number
- 880.2500
- Review Panel
- HO
- Submission Type