The following data is part of a premarket notification filed by Interventional Medical, Inc. with the FDA for Pressure Manometer.
| Device ID | K841071 |
| 510k Number | K841071 |
| Device Name: | PRESSURE MANOMETER |
| Classification | Wire, Guide, Catheter |
| Applicant | INTERVENTIONAL MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-04-17 |