K952725 is an FDA 510(k) clearance for the MULTICHECK. This device is classified as a Oximeter To Measure Hemoglobin (Class II - Special Controls, product code GLY).
Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on February 20, 1996, 251 days after receiving the submission on June 14, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K952725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1995 |
| Decision Date | February 20, 1996 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | GLY — Oximeter To Measure Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |