Echelon Spectroscopy Package
FDA 510(k) K071506 · Hitachi Medical Systems America, Inc.
510(k) numberK071506
Submission
- Device name
- Echelon Spectroscopy Package
- Applicant
- Hitachi Medical Systems America, Inc.
Twinsburg, OH, US - Received
- June 1, 2007
- Decision date
- June 28, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Echelon Spectroscopy Package cleared by the FDA?
Echelon Spectroscopy Package (K071506) received a 510(k) decision of Substantially Equivalent on June 28, 2007, 27 days after the submission was received.
What is the product code of K071506?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.