K970368 is an FDA 510(k) clearance for the SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on May 6, 1997, 95 days after receiving the submission on January 31, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K970368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1997 |
| Decision Date | May 06, 1997 |
| Days to Decision | 95 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 |