510(k) K880089
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