510(k) K914762
K914762 is an FDA 510(k) premarket notification submitted by Micromed for the device "MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR". The FDA issued a decision of Substantially Equivalent on December 5, 1991. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Micromed has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1991
- Date Received
- October 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type