Sunscope Intl., Inc.
Newport Beach, CA, US
Sunscope Intl., Inc. appears in FDA device records in Newport Beach, CA. FDA records list 7 510(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
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Sunscope Intl., Inc. between 1991 and 2000. The busiest year on record is 1998, with 3. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | FOZ | Substantially Equivalent | |
| K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | DRS | Substantially Equivalent | |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | |
| K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | Substantially Equivalent | |
| K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | DRS | Substantially Equivalent | |
| K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | Substantially Equivalent | |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | KRB | 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