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 |