FDA.report

510(k) K110398

Device
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
Applicant
RESPIRONICS, INC.
510(k) number
K110398
Product code
BZE  
Decision
Substantially Equivalent (SESE)
Decision date
2011-06-01
Date received
2011-02-11
Regulation
868.5270
Classification name
Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOSEPH E OLSAVSKY
Address
1740 Golden Mile Hwy. Murrysville PA US 15146 15146

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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