Search results with tag "Premarket"
REMstar Auto with CPAP : Premarket Notification
www.accessdata.fda.govThe Respironics REMstar 0 Series Auto with AFLEX CPAP System is a microprocessor controlled ... The REMstar Q Series Auto with AFLEX CPAP System includes the auto mode and the flex therapy feature cleared in K063830 ... premarket notification of intent to market the device
510(k) Premarket Notification Database
www.wholewellnessclub.netDatabase Updated 5/08/2007 CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Guide to Building a Successful 510(k) Submission
www.intertek.comIf you submit your 510(k) directly to the FDA, you must include a form 3601. For applications sent through a 3rd Party, such as Intertek, you may omit the form.. 2. CDRH Premarket Review Submission Cover Sheet . This is an optional form that is intended to provide the basic administrative information about the device and the firm submitting the 510(k) submission.
![Premarket Notification [510(k)] Submissions for Testing for …](/cache/preview/1/7/c/d/3/6/5/3/thumb-17cd3653bed96093b8fda5d566c37de2.jpg)
Premarket Notification [510(k)] Submissions for Testing for …
www.fda.gov3 premarket notification [510(k)] submissions for testing for skin sensitization to chemicals in natural rubber products guidance document a. purpose
PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA …
www.accessdata.fda.govERE ~PREMARKET NOTIFICATION 5 10(K) SUBMISSION Page 7 of 45 ROSA SURGICAL DEVICE Explanation of how the ROSA Surgical Device assists the neurosurgeon in planning device operates the position of instruments relative to preoperative images.