510(k) K944226
K944226 is an FDA 510(k) premarket notification submitted by Msi, Inc. for the device "MSI PROCEDURE KIT". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code DOX (Fluorometer, Lead (Dedicated Instruments)), a Class II device regulated under 21 CFR 862.3550. Msi, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1995
- Date Received
- August 30, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometer, Lead (Dedicated Instruments)
- Device Class
- Class II
- Regulation Number
- 862.3550
- Review Panel
- TX
- Submission Type