SAM IO Intraosseous Access System
FDA 510(k) K191488 · Sam® Medical Products, Inc.
510(k) numberK191488
Submission
- Device name
- SAM IO Intraosseous Access System
- Applicant
- Sam® Medical Products, Inc.
Wilsonville, OR, US - Received
- June 4, 2019
- Decision date
- November 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was SAM IO Intraosseous Access System cleared by the FDA?
SAM IO Intraosseous Access System (K191488) received a 510(k) decision of Substantially Equivalent on November 21, 2019, 170 days after the submission was received.
What is the product code of K191488?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.