The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Superlogger.
Device ID | K912772 |
510k Number | K912772 |
Device Name: | SUPERLOGGER |
Classification | Electrode, Ph, Stomach |
Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Contact | Judy Griffith |
Correspondent | Judy Griffith 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 | 1991-06-24 |
Decision Date | 1992-02-07 |