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 |