510(k) K932454
K932454 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M RED DOT 2330 RESTING EKG ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 16, 1993. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1993
- Date Received
- May 21, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type