510(k) K991568
K991568 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "MR SPECTROSCOPY PACKAGE". The FDA issued a decision of Substantially Equivalent on July 19, 1999. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1999
- Date Received
- May 5, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Spectroscopic
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type