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FDA 510(k)

CRITIKON 48-HOUR AIR ELIMINATING FILTER

K-Number: K861644 · 1986-07-22

ApplicantCritikon Company, LLC
Decision Date1986-07-22
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CRITIKON 48-HOUR AIR ELIMINATING FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1986-07-22 under 510(k) number K861644. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKON 48-HOUR AIR ELIMINATING FILTER?

CRITIKON 48-HOUR AIR ELIMINATING FILTER is a medical device that received FDA 510(k) clearance on 1986-07-22. The listed applicant is Critikon Company, LLC. The 510(k) number is K861644.

When did CRITIKON 48-HOUR AIR ELIMINATING FILTER receive FDA 510(k) clearance?

CRITIKON 48-HOUR AIR ELIMINATING FILTER received FDA 510(k) clearance on 1986-07-22, under 510(k) number K861644.

Who is the listed applicant for CRITIKON 48-HOUR AIR ELIMINATING FILTER?

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

What is the FDA product code for CRITIKON 48-HOUR AIR ELIMINATING FILTER?

The FDA product code for CRITIKON 48-HOUR AIR ELIMINATING FILTER is FPB.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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Related Devices (Code: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, 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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