The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Tempa-kuff Single Pat Pre-gaged Balanced Disp Cuff.
| Device ID | K925744 |
| 510k Number | K925744 |
| Device Name: | TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Contact | Robert A Lang |
| Correspondent | Robert A Lang PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1993-07-30 |