The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Ns Series Vacuum/pressure Gauges, Cuff Pressure Monitors.
| Device ID | K081778 |
| 510k Number | K081778 |
| Device Name: | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Doris F Walter |
| Correspondent | Doris F Walter INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2008-09-12 |
| Summary: | summary |