MR Spectroscopy Package
FDA 510(k) K991568 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK991568
Submission
- Device name
- MR Spectroscopy Package
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US - Received
- May 5, 1999
- Decision date
- July 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MR Spectroscopy Package cleared by the FDA?
MR Spectroscopy Package (K991568) received a 510(k) decision of Substantially Equivalent on July 19, 1999, 75 days after the submission was received.
What is the product code of K991568?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.