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FDA 510(k)

A.R.M. (ASPEN RETURN MONITOR)

K-Number: K873591 · 1987-09-30

ApplicantQmed, Inc.
Decision Date1987-09-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A.R.M. (ASPEN RETURN MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Qmed, Inc.. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K873591. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.R.M. (ASPEN RETURN MONITOR)?

A.R.M. (ASPEN RETURN MONITOR) is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is Qmed, Inc.. The 510(k) number is K873591.

When did A.R.M. (ASPEN RETURN MONITOR) receive FDA 510(k) clearance?

A.R.M. (ASPEN RETURN MONITOR) received FDA 510(k) clearance on 1987-09-30, under 510(k) number K873591.

Who is the listed applicant for A.R.M. (ASPEN RETURN MONITOR)?

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 A.R.M. (ASPEN RETURN MONITOR)?

The FDA product code for A.R.M. (ASPEN RETURN MONITOR) is GEI.

Related Clinical Trials

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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 ELECTROCARDIOGRAPHK862377QMED SELF ADHERING ELECTRODEK863091BICORD BY QMED

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Related Devices (Code: GEI)

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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