The following data is part of a premarket notification filed by Innovations For Mechanical Ventilation, Inc. with the FDA for Pressure Gauge.
| Device ID | K923800 |
| 510k Number | K923800 |
| Device Name: | PRESSURE GAUGE |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | INNOVATIONS FOR MECHANICAL VENTILATION, INC. 8 AMHERST RD. New City, NY 10956 |
| Contact | Ralph A Milliken |
| Correspondent | Ralph A Milliken INNOVATIONS FOR MECHANICAL VENTILATION, INC. 8 AMHERST RD. New City, NY 10956 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-29 |
| Decision Date | 1993-02-26 |