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FDA 510(k)

VISITEC 2 MICRON FLUID FILTER

K-Number: K853135 · 1985-08-09

ApplicantVisitec Co.
Decision Date1985-08-09
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC 2 MICRON FLUID FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1985-08-09 under 510(k) number K853135. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC 2 MICRON FLUID FILTER?

VISITEC 2 MICRON FLUID FILTER is a medical device that received FDA 510(k) clearance on 1985-08-09. The listed applicant is Visitec Co.. The 510(k) number is K853135.

When did VISITEC 2 MICRON FLUID FILTER receive FDA 510(k) clearance?

VISITEC 2 MICRON FLUID FILTER received FDA 510(k) clearance on 1985-08-09, under 510(k) number K853135.

Who is the listed applicant for VISITEC 2 MICRON FLUID FILTER?

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

What is the FDA product code for VISITEC 2 MICRON FLUID FILTER?

The FDA product code for VISITEC 2 MICRON FLUID FILTER is HQE.

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Other records listing Visitec Co. as applicant

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Related Devices (Code: HQE)

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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