The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Giphy Monitor.
Device ID | K883960 |
510k Number | K883960 |
Device Name: | GIPHY MONITOR |
Classification | Electrode, Ph, Stomach |
Applicant | VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
Contact | William R Oliver |
Correspondent | William R Oliver VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-20 |
Decision Date | 1989-10-04 |