510(k) K911308
K911308 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE". The FDA issued a decision of Substantially Equivalent on Sep 11, 1991. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Medical Equipment Designs, Inc. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 1991
- Date Received
- Mar 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type
- 510(k)