Suzuken Co., Ltd.
Great Neck, NY, US
Suzuken Co., Ltd. appears in FDA device records in Great Neck, NY. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Suzuken Co., Ltd. between 1981 and 2018. The busiest year on record is 1981, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 3 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 2001 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172068 | Kenz Cardico1211 | DPS | Substantially Equivalent | |
| K101024 | KENZ CARDY302 MAX | MWJ | Substantially Equivalent | |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | DRX | Substantially Equivalent | |
| K001896 | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC | DPS | Substantially Equivalent | |
| K870443 | KENZ-CARDICO 1201 | LOS | Substantially Equivalent | |
| K862544 | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K843731 | KENZ 80Z MARK II | DSI | Substantially Equivalent | |
| K822968 | ELECTROCARDIOGRAPH INTERPRETER | DSI | Substantially Equivalent | |
| K820854 | KENZ-45M | DXN | Substantially Equivalent | |
| K820991 | KENZ-GELECT GEL PAD | GYB | Substantially Equivalent | |
| K812263 | KENZ-GELECT | GYB | Substantially Equivalent | |
| K811950 | KENL-ECG | DPS | Substantially Equivalent | |
| K811949 | KENL-ECG-3 | DPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain