FDA 510(k)

REKA E100

K-Number: K111438 · 2011-09-12

Decision Date2011-09-12

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

REKA E100 is the device name listed in this FDA 510(k) record. The listed applicant is Reka Pte, Ltd.. It received FDA 510(k) clearance on 2011-09-12 under 510(k) number K111438. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REKA E100?

REKA E100 is a medical device that received FDA 510(k) clearance on 2011-09-12. The listed applicant is Reka Pte, Ltd.. The 510(k) number is K111438.

When did REKA E100 receive FDA 510(k) clearance?

REKA E100 received FDA 510(k) clearance on 2011-09-12, under 510(k) number K111438.

Who is the listed applicant for REKA E100?

The FDA 510(k) record lists Reka Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REKA E100?

The FDA product code for REKA E100 is DPS.

Related Devices (Code: DPS)

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.