510(k) K211651
K211651 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare, Ltd. for the device "Eclipse PRO". The FDA issued a decision of Substantially Equivalent on November 22, 2021. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Spacelabs Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2021
- Date Received
- May 28, 2021
- Clearance Type
- Traditional
- 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