The following data is part of a premarket notification filed by Contour Medical Technology, Inc. with the FDA for Quantum Edge Pediatric Defirbrillation Electrodes.
| Device ID | K970391 |
| 510k Number | K970391 |
| Device Name: | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. P.O. BOX 397 Lavergne, TN 37086 |
| Contact | R. Keith Ferrari |
| Correspondent | R. Keith Ferrari CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. P.O. BOX 397 Lavergne, TN 37086 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-03-06 |