510(k) K823287

RESPIRATORY CIRCUIT ADAPTOR by Thoratec Laboratories Corp. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1982
Date Received
November 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type