Sabratek Corp.
Chicago, IL, US
Sabratek Corp. appears in FDA device records in Chicago, IL. 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 Sabratek Corp. between 1992 and 1999. The busiest year on record is 1999, with 2. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983355 | SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR | FLL | Substantially Equivalent | |
| K980751 | SABRATEK 4040 INFUSION PUMP | FRN | Substantially Equivalent | |
| K980619 | SABRATEK PATIENT HOME MANAGEMENT SYSTEM | MHX | Substantially Equivalent | |
| K955258 | 3030 INFUSION PUMP | FRN | Substantially Equivalent | |
| K944293 | SABRATEK SABSIL SETS | FPA | Substantially Equivalent | |
| K941984 | SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K914589 | SABRATEK 3030 INFUSION PUMP | FRN | 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