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)

DEVILBISS SUCTION UNIT

K-Number: K982304 · 1998-09-25

ApplicantSunrise Medical Hhg, Inc.
Decision Date1998-09-25
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEVILBISS SUCTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 1998-09-25 under 510(k) number K982304. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS SUCTION UNIT?

DEVILBISS SUCTION UNIT is a medical device that received FDA 510(k) clearance on 1998-09-25. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K982304.

When did DEVILBISS SUCTION UNIT receive FDA 510(k) clearance?

DEVILBISS SUCTION UNIT received FDA 510(k) clearance on 1998-09-25, under 510(k) number K982304.

Who is the listed applicant for DEVILBISS SUCTION UNIT?

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

What is the FDA product code for DEVILBISS SUCTION UNIT?

The FDA product code for DEVILBISS SUCTION UNIT is JCX.

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 Sunrise Medical Hhg, 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.

K083249QUICKIE RHYTHMK012437DEVILBISS SLEEP RECORDER MODEL # RM60K020329DEVILBISS PD1000K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEMK011229DEVILBISS 9000 SERIES CPAP, MODEL 9001K003626DEVILBISS HUMIDIFIER

View all 10 devices →

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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.

↑