The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Rt40 Radio Translucent.
| Device ID | K912714 |
| 510k Number | K912714 |
| Device Name: | RT40 RADIO TRANSLUCENT |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO-DETEK, INC. 453 SOUTH MAIN ST., P.O. BOX 898 Attleboro, MA 02703 |
| Contact | Robert E Simmons |
| Correspondent | Robert E Simmons BIO-DETEK, INC. 453 SOUTH MAIN ST., P.O. BOX 898 Attleboro, MA 02703 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-07-25 |