The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Viggo Exacta Pressure Monitoring System.
Device ID | K870261 |
510k Number | K870261 |
Device Name: | VIGGO EXACTA PRESSURE MONITORING SYSTEM |
Classification | Stopcock, I.v. Set |
Applicant | OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Contact | Brim, Ph.d. |
Correspondent | Brim, Ph.d. OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-15 |
Decision Date | 1987-04-01 |