FDA 510(k)
Substantially Equivalent
🇺🇸 United States
KENZ-CARDICO 1201
K Number: K870443
·
Decision Jul 1, 1987
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
13
Review Days
148
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Basic Information
- Device Name
- KENZ-CARDICO 1201
- K Number
- K870443
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Suzuken Co., Ltd.
- Date Received
- February 3, 1987
- Decision Date
- July 1, 1987
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
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 |
| 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 |