510(k) K962364
K962364 is an FDA 510(k) premarket notification submitted by Codonics, Inc. for the device "CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)". The FDA issued a decision of Substantially Equivalent on November 8, 1996. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Codonics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1996
- Date Received
- June 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type