The following data is part of a premarket notification filed by Biometric Products, Inc. with the FDA for Model T 101 Clinical Transmitter.
| Device ID | K842435 |
| 510k Number | K842435 |
| Device Name: | MODEL T 101 CLINICAL TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | BIOMETRIC PRODUCTS, INC. 4275A SW 73RD AVE. Miami, FL 33155 |
| Contact | Louis Katchis |
| Correspondent | Louis Katchis BIOMETRIC PRODUCTS, INC. 4275A SW 73RD AVE. Miami, FL 33155 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-20 |
| Decision Date | 1985-05-16 |