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FDA 510(k)

QMED SYSTEM 2150

K-Number: K861437 · 1986-05-20

ApplicantQmed, Inc.
Decision Date1986-05-20
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QMED SYSTEM 2150 is the device name listed in this FDA 510(k) record. The listed applicant is Qmed, Inc.. It received FDA 510(k) clearance on 1986-05-20 under 510(k) number K861437. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMED SYSTEM 2150?

QMED SYSTEM 2150 is a medical device that received FDA 510(k) clearance on 1986-05-20. The listed applicant is Qmed, Inc.. The 510(k) number is K861437.

When did QMED SYSTEM 2150 receive FDA 510(k) clearance?

QMED SYSTEM 2150 received FDA 510(k) clearance on 1986-05-20, under 510(k) number K861437.

Who is the listed applicant for QMED SYSTEM 2150?

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

What is the FDA product code for QMED SYSTEM 2150?

The FDA product code for QMED SYSTEM 2150 is DXG.

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Other records listing Qmed, Inc. as applicant

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.

K972991MONITOR ONE NDXK932109PROFILOMATK921476INTERP-1000K897121QEKG ELECTROCARDIOGRAPHK873591A.R.M. (ASPEN RETURN MONITOR)K862377QMED SELF ADHERING ELECTRODE

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Related Devices (Code: DXG)

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.

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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.

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