Intl. Business Machines
Mchenry, IL, US
Intl. Business Machines appears in FDA device records in Mchenry, IL. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Intl. Business Machines between 1977 and 1983. The busiest year on record is 1981, with 3. The most recent is 1983, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1981 | 3 |
| 1983 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K831004 | AUTOMATED 8400 BLOOD CELL SEPARATOR | LKN | Substantially Equivalent | |
| K830163 | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS | DSI | Substantially Equivalent | |
| K812355 | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 | CAC | Substantially Equivalent | |
| K810989 | IBM 5880 ACQUISITION & ANALYSIS CART TEL | LOS | Substantially Equivalent | |
| K810988 | IBM 5885 DIGITAL ECG ACQUISITION CART | DPS | Substantially Equivalent | |
| K772353 | EKG ACQUISITION & ANALYSIS CART | LOS | Substantially Equivalent | |
| K771258 | BLOOD CELL SEPARATOR 2997 | GKT | Substantially Equivalent | |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | GKT | 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