FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENZ-GELECT
K Number: K812263
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
13
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KENZ-GELECT
- K Number
- K812263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Suzuken Co., Ltd.
- Date Received
- August 13, 1981
- Decision Date
- November 2, 1981
- Product Code
- GYB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYB), ordered by most recent decision date.
Jmoon Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
Avologi Gel Primer (Model: Av25)
FDA 510(k)
FDA Class 2
·Neurology
Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
EEG-acp
FDA 510(k)
FDA Class 2
·Neurology
AC Cream - Conductive paste
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |