K900001 is an FDA 510(k) clearance for the COROMETRICS MODEL 556 NEONATAL MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 29, 1990, 331 days after receiving the submission on January 2, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K900001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1990 |
| Decision Date | November 29, 1990 |
| Days to Decision | 331 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 |