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FDA 510(k)

HEMOR-ICE

K-Number: K854569 · 1986-02-05

ApplicantTechnology 2000
Decision Date1986-02-05
Product CodeLKX
DecisionSubstantially Equivalent

Device Summary

HEMOR-ICE is the device name listed in this FDA 510(k) record. The listed applicant is Technology 2000. It received FDA 510(k) clearance on 1986-02-05 under 510(k) number K854569. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOR-ICE?

HEMOR-ICE is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Technology 2000. The 510(k) number is K854569.

When did HEMOR-ICE receive FDA 510(k) clearance?

HEMOR-ICE received FDA 510(k) clearance on 1986-02-05, under 510(k) number K854569.

Who is the listed applicant for HEMOR-ICE?

The FDA 510(k) record lists Technology 2000 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOR-ICE?

The FDA product code for HEMOR-ICE is LKX.

Related Clinical Trials

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: LKX)

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.

K172358InstaliefPrivi Medical Pte, Ltd.K113660COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.K072414CRYOSTATLil Drug Store Products, Inc.K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International CorpK012746ICE BATONBehive, Ltd.K981428ANU ICECryoptherapy Pain Relief Products, 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.

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