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)

Insight BD

K-Number: K172832 · 2018-02-06

Decision Date2018-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Insight BD is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-02-06 under approval number K172832. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insight BD?

Insight BD is a medical device that received FDA 510(k) clearance on 2018-02-06. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K172832.

When was Insight BD approved by the FDA?

Insight BD received FDA 510(k) clearance on 2018-02-06, under approval number K172832.

What company makes Insight BD?

Insight BD is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for Insight BD?

The FDA product code for Insight BD is LLZ.

Other Devices by Siemens Medi Cal Solutions, Inc.

View all 14 devices →

Related Devices (Code: LLZ)

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.