The following data is part of a premarket notification filed by Airtronic Services, Inc. with the FDA for Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure Gauge.
| Device ID | K974775 |
| 510k Number | K974775 |
| Device Name: | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | AIRTRONIC SERVICES, INC. 116 NORTH LIVELY BLVD. Elk Grove Village, IL 60007 |
| Contact | Robert E Walter |
| Correspondent | Robert E Walter AIRTRONIC SERVICES, INC. 116 NORTH LIVELY BLVD. Elk Grove Village, IL 60007 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-02-19 |