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FDA 510(k)

IM BAND

K-Number: K113600 · 2012-02-08

ApplicantSynexmed(Shenzhen)Company Limited
Decision Date2012-02-08
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IM BAND is the device name listed in this FDA 510(k) record. The listed applicant is Synexmed(Shenzhen)Company Limited. It received FDA 510(k) clearance on 2012-02-08 under 510(k) number K113600. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IM BAND?

IM BAND is a medical device that received FDA 510(k) clearance on 2012-02-08. The listed applicant is Synexmed(Shenzhen)Company Limited. The 510(k) number is K113600.

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

IM BAND received FDA 510(k) clearance on 2012-02-08, under 510(k) number K113600.

Who is the listed applicant for IM BAND?

The FDA 510(k) record lists Synexmed(Shenzhen)Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IM BAND?

The FDA product code for IM BAND is DXC.

Other records listing Synexmed(Shenzhen)Company Limited 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.

K113148E-PASS

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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