ELECTROCARDIOGRAPHIC ECG RECORDER
FDA 510(k) clearance K781152 · decided 1978-08-31
Clearance details
- K-number
- K781152
- Device name
- ELECTROCARDIOGRAPHIC ECG RECORDER
- Applicant
- Cardio-Dynamics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-10
- Decision date
- 1978-08-31
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DSM
- Device class
- 1
- Regulation number
- 870.2640
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.