FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTROCARDIOGRAPHIC ECG RECORDER
K Number: K781152
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
4
Review Days
52
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Basic Information
- Device Name
- ELECTROCARDIOGRAPHIC ECG RECORDER
- K Number
- K781152
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2640
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardio-Dynamics Laboratories, Inc.
- Date Received
- July 10, 1978
- Decision Date
- August 31, 1978
- Product Code
- DSM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSM | Alarm, Leakage Current, Portable | FDA class 1 | Cardiovascular |