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FDA 510(k)

E-PASS

K-Number: K113148 · 2012-02-28

ApplicantSynexmed(Shenzhen)Company Limited
Decision Date2012-02-28
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

E-PASS 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 2012-02-28 under 510(k) number K113148. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-PASS?

E-PASS is a medical device that received FDA 510(k) clearance on 2012-02-28. The listed applicant is Synexmed(Shenzhen)Company Limited. The 510(k) number is K113148.

When did E-PASS receive FDA 510(k) clearance?

E-PASS received FDA 510(k) clearance on 2012-02-28, under 510(k) number K113148.

Who is the listed applicant for E-PASS?

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 E-PASS?

The FDA product code for E-PASS is DTL.

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.

K113600IM BAND

Related Devices (Code: DTL)

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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