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FDA 510(k)

TENSYN BAND

K-Number: K131850 · 2013-11-15

ApplicantDallen Medical, Inc.
Decision Date2013-11-15
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENSYN BAND is the device name listed in this FDA 510(k) record. The listed applicant is Dallen Medical, Inc.. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K131850. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENSYN BAND?

TENSYN BAND is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Dallen Medical, Inc.. The 510(k) number is K131850.

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

TENSYN BAND received FDA 510(k) clearance on 2013-11-15, under 510(k) number K131850.

Who is the listed applicant for TENSYN BAND?

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

What is the FDA product code for TENSYN BAND?

The FDA product code for TENSYN BAND is HTN.

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Other records listing Dallen Medical, Inc. 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.

K171473Compressyn™ StapleK132875COMPRESSYN STAPLEK130431COMPRESSYN BANDK122871COMPRESSYN STAPLE

Related Devices (Code: HTN)

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

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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