510(k) K132488
K132488 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL CODE WRITER". The FDA issued a decision of Substantially Equivalent on April 3, 2014. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2014
- Date Received
- August 8, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type