The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Manometer Set C.v.p. #s 298/299.
Device ID | K830910 |
510k Number | K830910 |
Device Name: | MANOMETER SET C.V.P. #S 298/299 |
Classification | Manometer, Blood-pressure, Venous |
Applicant | EXCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRK |
CFR Regulation Number | 870.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-21 |
Decision Date | 1983-04-05 |