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510(k) K834512

SANDMILL RMS by Sandhill Scientific, Inc. — Product Code FFT

K834512 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "SANDMILL RMS". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
December 21, 1983
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 Sandhill Scientific, Inc.

  • K111013 — ACEM (December 19, 2011)
  • K012232 — INSIGHT, MODEL S980000 (June 7, 2002)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002427 — SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (June 22, 2001)
  • K990441 — INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (May 12, 1999)
  • K984444 — INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (January 11, 1999)
  • K961056 — BIOVIEW MODEL S960000 (June 6, 1996)
  • K942247 — SMALL BOWEL ANALYSIS SOFTWARE (April 9, 1996)
  • K941801 — ANALGRAPH (September 8, 1995)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)

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)
  • K950087 — LOT 440 (February 6, 1996)
  • 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)

FDA data resources