510(k) K944684
K944684 is an FDA 510(k) premarket notification submitted by Mse Medizintechnik GmbH & Co. KG for the device "POLYSCAN DIGITAL SCANNER". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code IYW (Scanner, Rectilinear, Nuclear), a Class I device regulated under 21 CFR 892.1300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1995
- Date Received
- September 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Rectilinear, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1300
- Review Panel
- RA
- Submission Type