The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Sandhill Disposable Internal Reference Ph Probe.
Device ID | K931963 |
510k Number | K931963 |
Device Name: | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE |
Classification | Electrode, Ph, Stomach |
Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Contact | Jacqueline Q Thomas |
Correspondent | Jacqueline Q Thomas SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-21 |
Decision Date | 1994-09-28 |