510(k) K032466
K032466 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "SPIDERVIEW". The FDA issued a decision of Substantially Equivalent on August 22, 2003. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2003
- Date Received
- August 11, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory (Without Analysis)
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type