The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Viggo Insuflon.
| Device ID | K881767 |
| 510k Number | K881767 |
| Device Name: | VIGGO INSUFLON |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
| Contact | Jill Phillips |
| Correspondent | Jill Phillips OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1988-08-24 |