Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spinal Manometer NRFit; Spinal Manometer LUER

K-Number: K170305 · 2017-07-25

Decision Date2017-07-25
Product CodeFMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Spinal Manometer NRFit; Spinal Manometer LUER is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2017-07-25 under approval number K170305. The device is classified under product code FMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spinal Manometer NRFit; Spinal Manometer LUER?

Spinal Manometer NRFit; Spinal Manometer LUER is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K170305.

When was Spinal Manometer NRFit; Spinal Manometer LUER approved by the FDA?

Spinal Manometer NRFit; Spinal Manometer LUER received FDA 510(k) clearance on 2017-07-25, under approval number K170305.

What company makes Spinal Manometer NRFit; Spinal Manometer LUER?

Spinal Manometer NRFit; Spinal Manometer LUER is manufactured by PAJUNK GmbH Medizintechnologie.

What is the FDA product code for Spinal Manometer NRFit; Spinal Manometer LUER?

The FDA product code for Spinal Manometer NRFit; Spinal Manometer LUER is FMJ.

Other Devices by PAJUNK GmbH Medizintechnologie

View all 21 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.