|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
oracle oral mask
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K003894 |
06/25/2001
|
fisher & paykel healthecare oracle oral mask
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K023559 |
06/12/2003
|
single use oral mask, model hc455a
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K023670 |
06/12/2003
|
oracle oral mask, model hc451a
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K033087 |
01/14/2004
|
flexifil series hc431 full face mask, model hc431a
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K040506 |
05/05/2004
|
cpap humidifier, model hc234 (and related accessories)
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K040941 |
06/10/2004
|
hc604 cpap humidifier
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K041900 |
08/31/2004
|
cpap humidifier, model hc238jhu
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K050904 |
05/25/2005
|
flexifit hc432 full face mask
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K061236 |
08/29/2006
|
opus hc482 direct nasal mask
|
FISHER & PAYKEL HEALTHCARE, LTD.
|
K063036 |
12/22/2006
|