K892120 is an FDA 510(k) clearance for the ESCORT PULSE OXIMETRY OPTION. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on September 26, 1989, 179 days after receiving the submission on March 31, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K892120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1989 |
| Decision Date | September 26, 1989 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |