The following data is part of a premarket notification filed by Quinton Electrophysiology Corp. with the FDA for Eplab (electrocardiographic Monitor).
| Device ID | K893836 |
| 510k Number | K893836 |
| Device Name: | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | QUINTON ELECTROPHYSIOLOGY CORP. 3075 14TH AVENUE, SUITE 6 Markham, Ontario, CA L3r 2l6 |
| Contact | Harriet Schachter |
| Correspondent | Harriet Schachter QUINTON ELECTROPHYSIOLOGY CORP. 3075 14TH AVENUE, SUITE 6 Markham, Ontario, CA L3r 2l6 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-24 |
| Decision Date | 1989-09-08 |