The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Baxter Single Patient Use Blood Pressure Cuff.
| Device ID | K912007 |
| 510k Number | K912007 |
| Device Name: | BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach, FL 32960 |
| Contact | John Garrett |
| Correspondent | John Garrett TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach, FL 32960 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-07-22 |