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FDA 510(k)

REMEDY MODEL 2Z12

K-Number: K012029 · 2001-12-31

ApplicantApollo Corp.
Decision Date2001-12-31
Product CodeKMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REMEDY MODEL 2Z12 is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Corp.. It received FDA 510(k) clearance on 2001-12-31 under 510(k) number K012029. The device is classified under product code KMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEDY MODEL 2Z12?

REMEDY MODEL 2Z12 is a medical device that received FDA 510(k) clearance on 2001-12-31. The listed applicant is Apollo Corp.. The 510(k) number is K012029.

When did REMEDY MODEL 2Z12 receive FDA 510(k) clearance?

REMEDY MODEL 2Z12 received FDA 510(k) clearance on 2001-12-31, under 510(k) number K012029.

Who is the listed applicant for REMEDY MODEL 2Z12?

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

What is the FDA product code for REMEDY MODEL 2Z12?

The FDA product code for REMEDY MODEL 2Z12 is KMG.

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Related Devices (Code: KMG)

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.

K832288HEMOGLOBINOMETERMallinckrodt Critical CareK831253LANCER HEMOGLOBIN ANALYZER REAGENTSSherwood Medical Co.K813045AQUANOMICS, #SP36SFCooper-Hewitt Electric Co.K813049AQUANOMICS, #HHU100Cooper-Hewitt Electric Co.K813047AQUANOMICS, MINI 60LCooper-Hewitt Electric Co.K813048AQUANOMICS, #MP2SFCooper-Hewitt Electric Co.

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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