510(k) K820071

MODEL 5790 GAS CHROMATOGRAPH by Hewlett-Packard Co. — Product Code KZQ

K820071 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "MODEL 5790 GAS CHROMATOGRAPH". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
January 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography(Gas), Clinical Use
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type