510(k) Premarket Notification Database
Device Classification Name |
set, tubing and support, ventilator (w harness)
|
510(k) Number | K934753 |
Device Name | STAR BREATHING CIRCUITS |
Applicant |
INFRASONICS CORP.
|
3911 sorrento valley blvd. |
san diego,
CA
92121 140 |
|
Contact | jim hitchin |
Regulation Number | 868.5975 |
Classification Product Code |
|
Date Received | 10/04/1993 |
Decision Date | 10/27/1993 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Anesthesiology
|
Review Advisory Committee |
Anesthesiology
|
Statement/Summary/Purged Status |
Statement only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|