The following data is part of a premarket notification filed by Eutectic Electronics, Inc. with the FDA for Ultracompact.
| Device ID | K894968 |
| 510k Number | K894968 |
| Device Name: | ULTRACOMPACT |
| Classification | Uroflowmeter |
| Applicant | EUTECTIC ELECTRONICS, INC. 8608 JERSEY COURT Raleigh, NC 27612 |
| Contact | Larry Daniel |
| Correspondent | Larry Daniel EUTECTIC ELECTRONICS, INC. 8608 JERSEY COURT Raleigh, NC 27612 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-11-08 |