510(k) K042002
K042002 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER". The FDA issued a decision of Substantially Equivalent on October 20, 2004. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2004
- Date Received
- July 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type