510(k) K910450
K910450 is an FDA 510(k) premarket notification submitted by Medtech Industries, Inc. for the device "CARD GUARD-3000 ECG TELEPHONE ADAPTER". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Medtech Industries, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1991
- Date Received
- February 1, 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