The following data is part of a premarket notification filed by Browne Medical, Inc. with the FDA for Bedside N.p.t. 9900 - Printer 9800.
| Device ID | K830221 |
| 510k Number | K830221 |
| Device Name: | BEDSIDE N.P.T. 9900 - PRINTER 9800 |
| Classification | Monitor, Penile Tumescence |
| Applicant | BROWNE MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-03-17 |