The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Holter Kit Model #5000 Series.
| Device ID | K823414 |
| 510k Number | K823414 |
| Device Name: | HOLTER KIT MODEL #5000 SERIES |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | ANDOVER MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-15 |
| Decision Date | 1982-12-30 |