ZetrOZ Systems
Trumbull, CT, US
ZetrOZ Systems appears in FDA device records in Trumbull, CT. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for ZetrOZ Systems between 2020 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | PFW | Substantially Equivalent | |
| K233210 | sam CS Long Duration Ultrasound Device | PFW | Substantially Equivalent | |
| K223019 | sam 2.0 Long Ultrasound Device | PFW | Substantially Equivalent | |
| K211513 | sam X1 Long Duration Ultrasound Device | PFW | Substantially Equivalent | |
| K191568 | sam 2.0 Long Duration Ultrasound System | PFW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010765975 | 3010765975 | ZetrOZ Systems | 56 Quarry Rd, Trumbull, CT 06611 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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