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FDA 510(k)

HEMOBAND, MODELS HB-NS AND HB-NSXL

K-Number: K081740 · 2009-03-12

ApplicantInnovations For Access, Inc.
Decision Date2009-03-12
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOBAND, MODELS HB-NS AND HB-NSXL is the device name listed in this FDA 510(k) record. The listed applicant is Innovations For Access, Inc.. It received FDA 510(k) clearance on 2009-03-12 under 510(k) number K081740. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOBAND, MODELS HB-NS AND HB-NSXL?

HEMOBAND, MODELS HB-NS AND HB-NSXL is a medical device that received FDA 510(k) clearance on 2009-03-12. The listed applicant is Innovations For Access, Inc.. The 510(k) number is K081740.

When did HEMOBAND, MODELS HB-NS AND HB-NSXL receive FDA 510(k) clearance?

HEMOBAND, MODELS HB-NS AND HB-NSXL received FDA 510(k) clearance on 2009-03-12, under 510(k) number K081740.

Who is the listed applicant for HEMOBAND, MODELS HB-NS AND HB-NSXL?

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

What is the FDA product code for HEMOBAND, MODELS HB-NS AND HB-NSXL?

The FDA product code for HEMOBAND, MODELS HB-NS AND HB-NSXL is KOC.

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Related Devices (Code: KOC)

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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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