510(k) K833714

RESPIRATORY ASSESSMENT SYSTEM by Thoratec Laboratories Corp. — Product Code BZL

K833714 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "RESPIRATORY ASSESSMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.