FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROCARDIOGRAPH INTERPRETER
K Number: K822968
·
Decision Dec 15, 1982
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
13
Review Days
69
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Basic Information
- Device Name
- ELECTROCARDIOGRAPH INTERPRETER
- K Number
- K822968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Suzuken Co., Ltd.
- Date Received
- October 7, 1982
- Decision Date
- December 15, 1982
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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| K001896 | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC | Jan 8, 2001 | Substantially Equivalent |
| K870443 | KENZ-CARDICO 1201 | Jul 1, 1987 | Substantially Equivalent |
| K862544 | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH | Aug 6, 1986 | Substantially Equivalent |
| K843731 | KENZ 80Z MARK II | Jul 11, 1985 | Substantially Equivalent |
| K820854 | KENZ-45M | Jun 1, 1982 | Substantially Equivalent |
| K820991 | KENZ-GELECT GEL PAD | Apr 26, 1982 | Substantially Equivalent |
| K812263 | KENZ-GELECT | Nov 2, 1981 | Substantially Equivalent |