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FDA 510(k)

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER

K-Number: K862015 · 1986-07-22

ApplicantBipore, Inc.
Decision Date1986-07-22
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Bipore, Inc.. It received FDA 510(k) clearance on 1986-07-22 under 510(k) number K862015. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER?

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER is a medical device that received FDA 510(k) clearance on 1986-07-22. The listed applicant is Bipore, Inc.. The 510(k) number is K862015.

When did O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER receive FDA 510(k) clearance?

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER received FDA 510(k) clearance on 1986-07-22, under 510(k) number K862015.

Who is the listed applicant for O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER?

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

What is the FDA product code for O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER?

The FDA product code for O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER is FIB.

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Other records listing Bipore, Inc. as applicant

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Related Devices (Code: FIB)

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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