FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENZ 80Z MARK II
K Number: K843731
·
Decision Jul 11, 1985
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
13
Review Days
290
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Basic Information
- Device Name
- KENZ 80Z MARK II
- K Number
- K843731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Suzuken Co., Ltd.
- Date Received
- September 24, 1984
- Decision Date
- July 11, 1985
- 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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Other Clearances by Suzuken Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K172068 | Kenz Cardico1211 | Jun 1, 2018 | Substantially Equivalent |
| K101024 | KENZ CARDY302 MAX | Jan 6, 2011 | Substantially Equivalent |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Oct 13, 2009 | Substantially Equivalent |
| 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 |
| K822968 | ELECTROCARDIOGRAPH INTERPRETER | Dec 15, 1982 | 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 |