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)

FIL 1520

K-Number: K101629 · 2010-07-09

ApplicantGlenn Medical Systems, Inc.
Decision Date2010-07-09
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FIL 1520 is the device name listed in this FDA 510(k) record. The listed applicant is Glenn Medical Systems, Inc.. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K101629. 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 FIL 1520?

FIL 1520 is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Glenn Medical Systems, Inc.. The 510(k) number is K101629.

When did FIL 1520 receive FDA 510(k) clearance?

FIL 1520 received FDA 510(k) clearance on 2010-07-09, under 510(k) number K101629.

Who is the listed applicant for FIL 1520?

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

What is the FDA product code for FIL 1520?

The FDA product code for FIL 1520 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.

↑