The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Pneumogard Model 1230.
| Device ID | K781714 |
| 510k Number | K781714 |
| Device Name: | PNEUMOGARD MODEL 1230 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-06 |
| Decision Date | 1978-11-27 |