510(k) K142344
K142344 is an FDA 510(k) premarket notification submitted by Izi Medical Products, LLC for the device "DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Izi Medical Products, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2015
- Date Received
- August 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type