The following data is part of a premarket notification filed by Erie Medical with the FDA for Pressure Gauge.
| Device ID | K853040 |
| 510k Number | K853040 |
| Device Name: | PRESSURE GAUGE |
| Classification | Gauge, Gas Pressure, Cylinder/pipeline |
| Applicant | ERIE MEDICAL 4000 SOUTH 13TH ST. Milwaukee, WI 53221 |
| Contact | Steven A Case |
| Correspondent | Steven A Case ERIE MEDICAL 4000 SOUTH 13TH ST. Milwaukee, WI 53221 |
| Product Code | BXH |
| CFR Regulation Number | 868.2610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-10-10 |