The following data is part of a premarket notification filed by Contour Medical Technology, Inc. with the FDA for Noah Monitoring Electrode System.
| Device ID | K970125 |
| 510k Number | K970125 |
| Device Name: | NOAH MONITORING ELECTRODE SYSTEM |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. Lavergne, TN 37086 |
| Contact | Josh Trantum |
| Correspondent | Josh Trantum CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. Lavergne, TN 37086 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-03-04 |