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510(k) K950087

LOT 440 by Medical Instruments Corporation Mic AG — Product Code FFT

K950087 is an FDA 510(k) premarket notification submitted by Medical Instruments Corporation Mic AG for the device "LOT 440". The FDA issued a decision of Substantially Equivalent on February 6, 1996. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Medical Instruments Corporation Mic AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1996
Date Received
January 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type

Other clearances by Medical Instruments Corporation Mic AG

  • K991248 — PRONTO DRY (June 22, 1999)

Other clearances for product code FFT

  • K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIES (December 1, 2010)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002028 — BRAVO PH MONITORING SYSTEM (September 29, 2000)
  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920849 — TRIP CIC CATHETER (March 17, 1995)
  • K934434 — CYBERRX MODEL 7200 (January 24, 1995)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)

FDA data resources