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FDA 510(k)

EK DELIVERY DEVICE

K-Number: K121579 · 2012-10-03

ApplicantTdak Medical, Inc.
Decision Date2012-10-03
Product CodeOTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EK DELIVERY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tdak Medical, Inc.. It received FDA 510(k) clearance on 2012-10-03 under 510(k) number K121579. The device is classified under product code OTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EK DELIVERY DEVICE?

EK DELIVERY DEVICE is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is Tdak Medical, Inc.. The 510(k) number is K121579.

When did EK DELIVERY DEVICE receive FDA 510(k) clearance?

EK DELIVERY DEVICE received FDA 510(k) clearance on 2012-10-03, under 510(k) number K121579.

Who is the listed applicant for EK DELIVERY DEVICE?

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

What is the FDA product code for EK DELIVERY DEVICE?

The FDA product code for EK DELIVERY DEVICE is OTZ.

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Related Devices (Code: OTZ)

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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