510(k) K780260

TEMP. SENSOR W/22MM FITTINGS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KPD

K780260 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TEMP. SENSOR W/22MM FITTINGS". The FDA issued a decision of Substantially Equivalent on March 14, 1978. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1978
Date Received
February 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Temperature, Forehead, Liquid Crystal
Device Class
Class II
Regulation Number
880.2200
Review Panel
HO
Submission Type