The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Trimline 2000.
| Device ID | K943081 |
| 510k Number | K943081 |
| Device Name: | TRIMLINE 2000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PYMAH CORP. 89 ROUTE 206 P.O. BOX 1114 Somerville, NJ 08876 |
| Contact | George Levendusky |
| Correspondent | George Levendusky PYMAH CORP. 89 ROUTE 206 P.O. BOX 1114 Somerville, NJ 08876 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1995-01-27 |