The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Ns 120p-trs Airway Pressure Gauge.
| Device ID | K180510 |
| 510k Number | K180510 |
| Device Name: | NS 120P-TRS Airway Pressure Gauge |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | Instrumentation Industries, Inc. 2990 Industrial Blvd. Bethel Park, PA 15102 |
| Contact | Doris Walter |
| Correspondent | Doris 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 | 2018-02-27 |
| Decision Date | 2019-05-01 |