The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Monark Ergometers.
| Device ID | K912227 |
| 510k Number | K912227 |
| Device Name: | MONARK ERGOMETERS |
| Classification | Exerciser, Measuring |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-08-07 |