The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Viggo Exacta Pressure Monitoring Kit.
| Device ID | K864900 |
| 510k Number | K864900 |
| Device Name: | VIGGO EXACTA PRESSURE MONITORING KIT |
| 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 |