Hemosonic 200HEMODYNAMIC Monitor
FDA 510(k) K040802 · Arrow Intl., Inc.
510(k) numberK040802
Submission
- Device name
- Hemosonic 200HEMODYNAMIC Monitor
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- March 29, 2004
- Decision date
- April 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPN – Thin Layer Chromatography, Propoxyphene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3700
- Specialty
- Clinical Toxicology
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Questions and answers
When was Hemosonic 200HEMODYNAMIC Monitor cleared by the FDA?
Hemosonic 200HEMODYNAMIC Monitor (K040802) received a 510(k) decision of Substantially Equivalent on April 28, 2004, 30 days after the submission was received.
What is the product code of K040802?
The FDA product code is DPN – Thin Layer Chromatography, Propoxyphene, a Class II (moderate risk) device regulated under 21 CFR 862.3700.