K152553 is an FDA 510(k) clearance for the CueSee Hypoxic. This device is classified as a Controls For Blood-gases, (assayed And Unassayed) (Class I - General Controls, product code JJS).
Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on April 22, 2016, 227 days after receiving the submission on September 8, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K152553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2015 |
| Decision Date | April 22, 2016 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJS - Controls For Blood-gases, (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |