The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Slimline 3000.
Device ID | K934180 |
510k Number | K934180 |
Device Name: | SLIMLINE 3000 |
Classification | Blood Pressure Cuff |
Applicant | PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
Contact | Bernard Konopko |
Correspondent | Bernard Konopko PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-27 |
Decision Date | 1993-11-24 |