FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
K Number: K001896
·
Decision Jan 8, 2001
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
13
Review Days
201
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Basic Information
- Device Name
- KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
- K Number
- K001896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzuken Co., Ltd.
- Date Received
- June 21, 2000
- Decision Date
- January 8, 2001
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 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 |
| 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 |
| 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 |