510(k) K880089

FINNIGAN MAT TSQ-70 by Finnigan Corp. — Product Code DOP

K880089 is an FDA 510(k) premarket notification submitted by Finnigan Corp. for the device "FINNIGAN MAT TSQ-70". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860. Finnigan Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
January 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mass Spectrometer, Clinical Use
Device Class
Class I
Regulation Number
862.2860
Review Panel
TX
Submission Type