IMAGE3 SE DISPOSABLE FULL FACE MASK

Ventilator, Continuous, Facility Use

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Image3 Se Disposable Full Face Mask.

Pre-market Notification Details

Device IDK023135
510k NumberK023135
Device Name:IMAGE3 SE DISPOSABLE FULL FACE MASK
ClassificationVentilator, Continuous, Facility Use
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactZita A Yurko
CorrespondentZita A Yurko
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-20
Decision Date2003-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959042544 K023135 000
30606959028433 K023135 000
30606959028440 K023135 000
30606959034373 K023135 000
30606959034380 K023135 000
30606959034397 K023135 000
00606959041813 K023135 000
00606959041820 K023135 000
00606959041837 K023135 000
00606959042551 K023135 000
00606959042568 K023135 000
30606959028426 K023135 000
30606959028419 K023135 000
00606959042582 K023135 000
00606959024762 K023135 000
00606959024779 K023135 000
00606959024786 K023135 000
00606959024793 K023135 000
30606959027689 K023135 000
30606959027696 K023135 000
30606959027702 K023135 000
30606959028396 K023135 000
30606959028402 K023135 000
00606959042599 K023135 000
00606959042605 K023135 000
30606959000699 K023135 000
00606959007673 K023135 000
00606959007680 K023135 000
00606959009455 K023135 000
00606959009462 K023135 000
00606959009479 K023135 000
00606959011601 K023135 000
00606959011618 K023135 000
00606959011625 K023135 000
00606959014909 K023135 000
00606959014916 K023135 000
00606959007666 K023135 000
30606959007629 K023135 000
30606959000705 K023135 000
30606959000712 K023135 000
00606959000773 K023135 000
00606959000780 K023135 000
00606959000797 K023135 000
30606959007544 K023135 000
30606959007551 K023135 000
30606959007568 K023135 000
30606959007605 K023135 000
30606959007612 K023135 000
00606959014923 K023135 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.