The following data is part of a premarket notification filed by Newmed Corp. with the FDA for Newmed Abp-lite.
| Device ID | K955887 |
| 510k Number | K955887 |
| Device Name: | NEWMED ABP-LITE |
| Classification | System, Phonocatheter, Intracavitary |
| Applicant | NEWMED CORP. 1575 EYE ST., N.W. Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone NEWMED CORP. 1575 EYE ST., N.W. Washington, DC 20005 |
| Product Code | DXW |
| CFR Regulation Number | 870.1270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-28 |
| Decision Date | 1996-09-05 |
| Summary: | summary |