The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Holter Recorder & Playback/analysis Sys.
| Device ID | K822818 |
| 510k Number | K822818 |
| Device Name: | HOLTER RECORDER & PLAYBACK/ANALYSIS SYS |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | MARQUETTE ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-20 |
| Decision Date | 1982-12-30 |