K091787 is an FDA 510(k) clearance for the MODEL 6000 TWO PARAMETER BEDSIDE MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on October 9, 2009, 114 days after receiving the submission on June 17, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K091787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |