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510(k) K880418

INCOS 50 MASS SPECTROMETER by Finnigan Corp. — Product Code DOP

K880418 is an FDA 510(k) premarket notification submitted by Finnigan Corp. for the device "INCOS 50 MASS SPECTROMETER". The FDA issued a decision of Substantially Equivalent on May 31, 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
May 31, 1988
Date Received
February 1, 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

Other clearances by Finnigan Corp.

  • K880090 — ION TRAP DETECTOR (March 15, 1988)
  • K880089 — FINNIGAN MAT TSQ-70 (February 11, 1988)
  • K873603 — FINNIGAN MAT INCOS 50 (September 22, 1987)

Other clearances for product code DOP

  • K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (July 13, 1999)
  • K974322 — ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (December 16, 1997)
  • K880090 — ION TRAP DETECTOR (March 15, 1988)
  • K880089 — FINNIGAN MAT TSQ-70 (February 11, 1988)
  • K872464 — ION TRAP DETECTOR (ITD) (August 11, 1987)
  • K854076 — MGA 2000 GAS ANALYSER (December 11, 1985)
  • K810938 — MASS SPECTROMETER-MEDSPECT II (April 23, 1981)
  • K770994 — FURNACE AUTOSAMPLER, MODEL 155 (August 22, 1977)
  • K770637 — MERCURY/HYDRIDE SYSTEM MHS-1 (June 23, 1977)

FDA data resources