K925910 is an FDA 510(k) clearance for the HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE. This device is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II - Special Controls, product code KLK).
Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on July 29, 1993, 248 days after receiving the submission on November 23, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K925910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1992 |
| Decision Date | July 29, 1993 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2500 |