510(k) K030316
K030316 is an FDA 510(k) premarket notification submitted by Inovise Medical, Inc. for the device "AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)". The FDA issued a decision of Substantially Equivalent on August 7, 2003. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Inovise Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2003
- Date Received
- January 30, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type