510(k) K001288
K001288 is an FDA 510(k) premarket notification submitted by North East Monitoring, Inc. for the device "DR180-II". The FDA issued a decision of Substantially Equivalent on July 20, 2000. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. North East Monitoring, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2000
- Date Received
- April 24, 2000
- Clearance Type
- Abbreviated
- 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