The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for S&w Electrode Types 888, 844, 988 And 944.
| Device ID | K864586 |
| 510k Number | K864586 |
| Device Name: | S&W ELECTRODE TYPES 888, 844, 988 AND 944 |
| Classification | Electrode, Electrocardiograph |
| Applicant | S & W MEDICO TEKNIK HAIGHT, GARDNER, POOR & HAVENS ONE STATE STREET PLAZA New York, NY 10004 |
| Contact | Lennard K Rambusch |
| Correspondent | Lennard K Rambusch S & W MEDICO TEKNIK HAIGHT, GARDNER, POOR & HAVENS ONE STATE STREET PLAZA New York, NY 10004 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-21 |
| Decision Date | 1987-03-13 |