510(k) K781152
K781152 is an FDA 510(k) premarket notification submitted by Cardio-Dynamics Laboratories, Inc. for the device "ELECTROCARDIOGRAPHIC ECG RECORDER". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code DSM (Alarm, Leakage Current, Portable), a Class I device regulated under 21 CFR 870.2640. Cardio-Dynamics Laboratories, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1978
- Date Received
- July 10, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Leakage Current, Portable
- Device Class
- Class I
- Regulation Number
- 870.2640
- Review Panel
- CV
- Submission Type