510(k) K991473
K991473 is an FDA 510(k) premarket notification submitted by Intelligence Artificielle Applications for the device "SIRSCAN". The FDA issued a decision of Substantially Equivalent on November 23, 1999. The device falls under product code KZK (Reader, Zone, Automated), a Class I device regulated under 21 CFR 866.2850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1999
- Date Received
- April 27, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reader, Zone, Automated
- Device Class
- Class I
- Regulation Number
- 866.2850
- Review Panel
- MI
- Submission Type