Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

E.M.A.

K-Number: K940614 · 1994-04-06

ApplicantEuropean Manufacturers Agency, Inc.
Decision Date1994-04-06
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

E.M.A. is the device name listed in this FDA 510(k) record. The listed applicant is European Manufacturers Agency, Inc.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K940614. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E.M.A.?

E.M.A. is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is European Manufacturers Agency, Inc.. The 510(k) number is K940614.

When did E.M.A. receive FDA 510(k) clearance?

E.M.A. received FDA 510(k) clearance on 1994-04-06, under 510(k) number K940614.

Who is the listed applicant for E.M.A.?

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

What is the FDA product code for E.M.A.?

The FDA product code for E.M.A. is HQZ.

Other records listing European Manufacturers Agency, 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.

K940613E.M.A.K940612E.M.A.

Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945770OPTICAL FRAMESRamada Optics, Inc.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.

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.

↑