The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Bioview Model S960000.
Device ID | K961056 |
510k Number | K961056 |
Device Name: | BIOVIEW MODEL S960000 |
Classification | Monitor, Esophageal Motility, And Tube |
Applicant | SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
Contact | Linda Diederich |
Correspondent | Linda Diederich SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
Product Code | KLA |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-18 |
Decision Date | 1996-06-06 |