The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Hill Tube.
Device ID | K771723 |
510k Number | K771723 |
Device Name: | HILL TUBE |
Classification | Monitor, Esophageal Motility, And Tube |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLA |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-13 |
Decision Date | 1977-11-22 |