510(k) K813318
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