510(k) K922483
K922483 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT COMPACT DAYLIGHT SYSTEM 2000". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1992
- Date Received
- May 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Changer, Radiographic Film/Cassette
- Device Class
- Class II
- Regulation Number
- 892.1860
- Review Panel
- RA
- Submission Type