The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Sandhill Scientific Pediatec Ph Probe.
| Device ID | K013951 |
| 510k Number | K013951 |
| Device Name: | SANDHILL SCIENTIFIC PEDIATEC PH PROBE |
| Classification | Electrode, Ph, Stomach |
| Applicant | SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-30 |
| Decision Date | 2002-02-28 |
| Summary: | summary |