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)

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER

K-Number: K934509 · 1993-10-21

ApplicantSdi Diagnostics, Inc.
Decision Date1993-10-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K934509. 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 PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER?

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K934509.

When did PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER receive FDA 510(k) clearance?

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER received FDA 510(k) clearance on 1993-10-21, under 510(k) number K934509.

Who is the listed applicant for PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER?

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

What is the FDA product code for PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER?

The FDA product code for PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER is CAH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sdi Diagnostics, 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.

K150515IQSense Flow Sensor MouthpieceK092813ASTRASONIC SPIROMETER, MODEL 29-8000K061571ASTRA 300K062913ASTRAGUARD PULMONARY FUNCTION FILTERK033939FLOSENSE II, MODEL 29-8040K031643SPIROTEL, MODEL 29-1020

View all 10 devices →

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.

↑