FDA.report

510(k) K102483

Device
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
Applicant
SUNSET HEALTHCARE SOLUTIONS, LLC
510(k) number
K102483
Product code
CAH  
Decision
Substantially Equivalent (SESE)
Decision date
2011-09-13
Date received
2010-08-30
Regulation
868.5260
Classification name
Filter, Bacterial, Breathing-circuit
Medical specialty
Anesthesiology
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kevin Walls
Address
5401 S Cottonwood Ct. Greenwood Village CO US 80121 80121

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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00848530099749Bacteria FilterSUNSET HEALTHCARE SOLUTIONS, INC.2024-06-07
10609038938216AVANOSAvanos Medical, Inc.2020-02-26

Legacy Summary

summary

FDA Review

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