PMA supplement
P820019 S003: LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE
FDA PMA supplement · Biochem International, Inc.
Key facts
| Original PMA | P820019 |
|---|---|
| Supplement number | S003 |
| Trade name | LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE |
| Generic name | MONITOR, CARBON-DIOXIDE, CUTANEOUS |
| Applicant | Biochem International, Inc. |
| Product code | LKD |
| Received date | May 8, 1984 |
| Decision date | Aug 21, 1985 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: