K980756 is an FDA 510(k) clearance for the COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE. This device is classified as a Monitor, Carbon-dioxide, Cutaneous (Class II - Special Controls, product code LKD).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 5, 1998, 251 days after receiving the submission on February 27, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2480.
| 510(k) Number | K980756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1998 |
| Decision Date | November 05, 1998 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | LKD - Monitor, Carbon-dioxide, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2480 |