Prima, Inc.
Cleveland, TN, US
Prima, Inc. appears in FDA device records in Cleveland, TN. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Prima, Inc. between 1994 and 1995. The busiest year on record is 1995, with 14. The most recent is 1995, with 14.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 5 |
| 1995 | 14 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952022 | PRIMA VOLUMN VENTILATORSS | BZO | Substantially Equivalent | |
| K952021 | PRIMA HYUPERINFLATION SYSTEM | BZR | Substantially Equivalent | |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | CAI | Substantially Equivalent | |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | CAI | Substantially Equivalent | |
| K952018 | PRIMA COAXIAL CIRCUITS | CAI | Substantially Equivalent | |
| K952017 | PRIMA MAPLESON D CIRCUIT | CAI | Substantially Equivalent | |
| K952016 | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | CAI | Substantially Equivalent | |
| K952015 | PRIMA FILTER | CAH | Substantially Equivalent | |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | CAI | Substantially Equivalent | |
| K952013 | PRIMA GUEDEL AIRWAYS | BTR | Substantially Equivalent | |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | BZO | Substantially Equivalent | |
| K952011 | PRIMA BREATHING BAGS | BZO | Substantially Equivalent | |
| K952010 | PRIMA VENTILATOR HOSES | BZO | Substantially Equivalent | |
| K952009 | PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS | CAI | Substantially Equivalent | |
| K944532 | PRIMA, INC. VENTILATOR HOSES | BZA | Substantially Equivalent | |
| K944531 | PRIMA, INC. CORRUGATED TUBING | BZO | Substantially Equivalent | |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | BZA | Substantially Equivalent | |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | BZA | Substantially Equivalent | |
| K944533 | PRIMA, INC. ADULT ANESTHESIA CIRCUIT | CAI | 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