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FDA 510(k)

COMPRESSYN BAND

K-Number: K101484 · 2011-04-01

ApplicantDallen Medical
Decision Date2011-04-01
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPRESSYN BAND is the device name listed in this FDA 510(k) record. The listed applicant is Dallen Medical. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K101484. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPRESSYN BAND?

COMPRESSYN BAND is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Dallen Medical. The 510(k) number is K101484.

When did COMPRESSYN BAND receive FDA 510(k) clearance?

COMPRESSYN BAND received FDA 510(k) clearance on 2011-04-01, under 510(k) number K101484.

Who is the listed applicant for COMPRESSYN BAND?

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

What is the FDA product code for COMPRESSYN BAND?

The FDA product code for COMPRESSYN BAND is JDQ.

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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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