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FDA 510(k)

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS

K-Number: K943654 · 1995-08-02

ApplicantMdt Biologic Co.
Decision Date1995-08-02
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Mdt Biologic Co.. It received FDA 510(k) clearance on 1995-08-02 under 510(k) number K943654. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS?

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Mdt Biologic Co.. The 510(k) number is K943654.

When did HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS receive FDA 510(k) clearance?

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS received FDA 510(k) clearance on 1995-08-02, under 510(k) number K943654.

Who is the listed applicant for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS?

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

What is the FDA product code for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS?

The FDA product code for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS is MLR.

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Other records listing Mdt Biologic Co. 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: MLR)

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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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