The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Display Box #60000/tubing Set #61000.
| Device ID | K852232 |
| 510k Number | K852232 |
| Device Name: | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Ronald A Williams |
| Correspondent | Ronald A Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-22 |
| Decision Date | 1985-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169200999 | K852232 | 000 |
| 20613994846666 | K852232 | 000 |
| 20613994846642 | K852232 | 000 |
| 20613994846628 | K852232 | 000 |
| 20613994846604 | K852232 | 000 |