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

FDA 510(k)

SAM Model 9-10000

K-Number: K240100 · 2024-06-04

Decision Date2024-06-04
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAM Model 9-10000 is the device name listed in this FDA 510(k) record. The listed applicant is Snap Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K240100. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAM Model 9-10000?

SAM Model 9-10000 is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Snap Diagnostics, LLC. The 510(k) number is K240100.

When did SAM Model 9-10000 receive FDA 510(k) clearance?

SAM Model 9-10000 received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240100.

Who is the listed applicant for SAM Model 9-10000?

The FDA 510(k) record lists Snap Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAM Model 9-10000?

The FDA product code for SAM Model 9-10000 is MNR.

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.