The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton 901 & 900 Holter Scanner.
| Device ID | K841611 |
| 510k Number | K841611 |
| Device Name: | QUINTON 901 & 900 HOLTER SCANNER |
| Classification | Electrocardiograph |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-08-02 |