Sandhill Disposable Internal Reference Ph Probe

• • Terminated Z-0104-04 FDA Unclassified (pre-2012) ·initiated 24 Sep 2003

  Pouch containing pediatric probes was labeled as containing adult probes.

• • Terminated Z-0466-03 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003

  Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

510(k) Number

K931963 ↗

FDA Product Code

FFT

Device Class

Class I

Regulation

21 CFR Part 876.1400

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Superlogger

  Class I

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