510(k) K022342
K022342 is an FDA 510(k) premarket notification submitted by Anzai Medical Co., Ltd. for the device "EZ-SCOPE AN, EZ-SCOPE LIGHT". The FDA issued a decision of Substantially Equivalent on Oct 9, 2002. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Anzai Medical Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2002
- Date Received
- Jul 18, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type
- 510(k)