Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BACT-TRAP HEPA MIDI

K-Number: K093426 · 2010-02-22

ApplicantPharma Systems AB
Decision Date2010-02-22
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BACT-TRAP HEPA MIDI is the device name listed in this FDA 510(k) record. The listed applicant is Pharma Systems AB. It received FDA 510(k) clearance on 2010-02-22 under 510(k) number K093426. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACT-TRAP HEPA MIDI?

BACT-TRAP HEPA MIDI is a medical device that received FDA 510(k) clearance on 2010-02-22. The listed applicant is Pharma Systems AB. The 510(k) number is K093426.

When did BACT-TRAP HEPA MIDI receive FDA 510(k) clearance?

BACT-TRAP HEPA MIDI received FDA 510(k) clearance on 2010-02-22, under 510(k) number K093426.

Who is the listed applicant for BACT-TRAP HEPA MIDI?

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

What is the FDA product code for BACT-TRAP HEPA MIDI?

The FDA product code for BACT-TRAP HEPA MIDI is CAH.

Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.

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.

↑