Viggo Exacta Pressure Monitoring System
FDA 510(k) K870261 · Ohmeda Medical
510(k) numberK870261
Submission
- Device name
- Viggo Exacta Pressure Monitoring System
- Applicant
- Ohmeda Medical
Tampa, FL, US - Received
- December 15, 1986
- Decision date
- April 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Viggo Exacta Pressure Monitoring System cleared by the FDA?
Viggo Exacta Pressure Monitoring System (K870261) received a 510(k) decision of Substantially Equivalent on April 1, 1987, 107 days after the submission was received.
What is the product code of K870261?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.