K970061 is an FDA 510(k) clearance for the ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on September 25, 1997, 261 days after receiving the submission on January 7, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K970061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1997 |
| Decision Date | September 25, 1997 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |