The following data is part of a premarket notification filed by Bristol Medical Electronics Corp. with the FDA for Me20 Tracerite Clear Vent Tape, Me30 Tracerite Non.
| Device ID | K844856 |
| 510k Number | K844856 |
| Device Name: | ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON |
| Classification | Electrode, Electrocardiograph |
| Applicant | BRISTOL MEDICAL ELECTRONICS CORP. 171C FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Contact | Donald C Epstein |
| Correspondent | Donald C Epstein BRISTOL MEDICAL ELECTRONICS CORP. 171C FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-14 |
| Decision Date | 1985-02-20 |