NMCClass II
Mask, Ventilator, Non-continuous, Reprocessed
Anesthesiology · 21 CFR 868.5905
Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure). Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
MDR events16All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
16 adverse event reports on file
- ALLEN COMFORT MASK DISPOSABLEJul 13, 2012OtherAllen Medical1221538-2012-00005
- ALLEN C-PRONE COMFORT MASKNov 17, 2009OtherAllen Medical1221538-2009-00012
- COMFORT GELAug 19, 2008InjuryRespironicsMW5008032
- RESPIRONICS COMFORTGEL MASKAug 1, 2008MalfunctionRespironicsMW5007866
- RESPIRONICSMay 15, 2008MalfunctionMW5006932
- RESPRONICSMar 22, 2008MalfunctionRespironicsMW5006035
- FLEXIFIT HC405 NASAL MASKJun 1, 2007MalfunctionFisher & Paykel Healthcare9611451-2007-00189
- ACLAIM 401 NASAL MASKApr 13, 2007MalfunctionFisher & Paykel Healthcare, Ltd.9611451-2007-00121
- HC431NIVApr 5, 2007OtherFisher & Paykel Healthcare, Ltd.9611451-2007-00031
- HC431NIVApr 5, 2007OtherFisher & Paykel Healthcare, Ltd.9611451-2007-00030
Event type breakdown
Malfunction8
Other5
Injury2
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.