K081778 is an FDA 510(k) clearance for the NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on September 12, 2008, 81 days after receiving the submission on June 23, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K081778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2008 |
| Decision Date | September 12, 2008 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2600 |