510(k) K813318

MINI-SHAKER by Dynatech Corp. — Product Code JRQ

K813318 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "MINI-SHAKER". The FDA issued a decision of Substantially Equivalent on December 17, 1981. The device falls under product code JRQ (Shaker/Stirrer), a Class I device regulated under 21 CFR 862.2050. Dynatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shaker/Stirrer
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type