Home / 510(k) Clearances / K992163

510(k) K992163

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS by Pdz-Europa , Ltd. — Product Code DOP

K992163 is an FDA 510(k) premarket notification submitted by Pdz-Europa , Ltd. for the device "ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS". The FDA issued a decision of Substantially Equivalent on July 13, 1999. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1999
Date Received
June 25, 1999
Clearance Type
Special
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 for product code DOP

  • K974322 — ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (December 16, 1997)
  • K880418 — INCOS 50 MASS SPECTROMETER (May 31, 1988)
  • 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