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FDA 510(k)

EASTLYTE NA/K/CA/PH

K-Number: K112788 · 2011-10-20

ApplicantMedica Corp.
Decision Date2011-10-20
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASTLYTE NA/K/CA/PH is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K112788. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASTLYTE NA/K/CA/PH?

EASTLYTE NA/K/CA/PH is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Medica Corp.. The 510(k) number is K112788.

When did EASTLYTE NA/K/CA/PH receive FDA 510(k) clearance?

EASTLYTE NA/K/CA/PH received FDA 510(k) clearance on 2011-10-20, under 510(k) number K112788.

Who is the listed applicant for EASTLYTE NA/K/CA/PH?

The FDA 510(k) record lists Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASTLYTE NA/K/CA/PH?

The FDA product code for EASTLYTE NA/K/CA/PH is CEM.

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Related Devices (Code: CEM)

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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