RESPIRONICS SUCTIONEASY

Catheters, Suction, Tracheobronchial

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Suctioneasy.

Pre-market Notification Details

Device IDK882017
510k NumberK882017
Device Name:RESPIRONICS SUCTIONEASY
ClassificationCatheters, Suction, Tracheobronchial
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactEugene N Scarberry
CorrespondentEugene N Scarberry
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-13
Decision Date1988-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10860007555326 K882017 000
00860007555329 K882017 000
00860007555336 K882017 000

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