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FDA 510(k)

BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY

K-Number: K844625 · 1985-01-16

ApplicantBipore, Inc.
Decision Date1985-01-16
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Bipore, Inc.. It received FDA 510(k) clearance on 1985-01-16 under 510(k) number K844625. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY?

BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY is a medical device that received FDA 510(k) clearance on 1985-01-16. The listed applicant is Bipore, Inc.. The 510(k) number is K844625.

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

BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY received FDA 510(k) clearance on 1985-01-16, under 510(k) number K844625.

Who is the listed applicant for BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY?

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 BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY?

The FDA product code for BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY is KOZ.

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Other records listing Bipore, Inc. 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.

K073434BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERK073318BIPORE BALLOON DILATION CATHETERK051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERK041293BIOPORE BALLOON DILATION CATHETERK983650BIPORE BALLOON DILATATION CATHETERK973563BIPORE BALLOON DILATATION CATHETER

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Related Devices (Code: KOZ)

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.

K905206INCARE PINSITE DRESSINGHollister, Inc.K905688CUTINOVA HYDROBeiersdorf, Inc.K905069IODOSORB GELPerstorp AB C/O Robert Joel SlomoffK904604REDI-RELEASE ABSORBENT DRESSINGFountain Pharmaceuticals, Inc.K896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, A Division of E.R. Squibb & Sons

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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