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FDA 510(k)

HABIB 4X

K-Number: K051420 · 2005-08-15

ApplicantEmcision , Ltd.
Decision Date2005-08-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HABIB 4X is the device name listed in this FDA 510(k) record. The listed applicant is Emcision , Ltd.. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K051420. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HABIB 4X?

HABIB 4X is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is Emcision , Ltd.. The 510(k) number is K051420.

When did HABIB 4X receive FDA 510(k) clearance?

HABIB 4X received FDA 510(k) clearance on 2005-08-15, under 510(k) number K051420.

Who is the listed applicant for HABIB 4X?

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

What is the FDA product code for HABIB 4X?

The FDA product code for HABIB 4X is GEI.

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Other records listing Emcision , Ltd. 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.

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Related Devices (Code: GEI)

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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