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FDA 510(k)

AFF (MARK I) VOLUMETRIC INFUSION PUMP

K-Number: K070529 · 2007-05-08

ApplicantDefinitive Medical Technologies, Ltd.
Decision Date2007-05-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AFF (MARK I) VOLUMETRIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Definitive Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2007-05-08 under 510(k) number K070529. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFF (MARK I) VOLUMETRIC INFUSION PUMP?

AFF (MARK I) VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2007-05-08. The listed applicant is Definitive Medical Technologies, Ltd.. The 510(k) number is K070529.

When did AFF (MARK I) VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

AFF (MARK I) VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 2007-05-08, under 510(k) number K070529.

Who is the listed applicant for AFF (MARK I) VOLUMETRIC INFUSION PUMP?

The FDA 510(k) record lists Definitive Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFF (MARK I) VOLUMETRIC INFUSION PUMP?

The FDA product code for AFF (MARK I) VOLUMETRIC INFUSION PUMP is FRN.

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Related Devices (Code: FRN)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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