The following data is part of a premarket notification filed by R & D Medical Products, Inc. with the FDA for Neonatal Ecg Electrode, M203ken.
| Device ID | K092744 |
| 510k Number | K092744 |
| Device Name: | NEONATAL ECG ELECTRODE, M203KEN |
| Classification | Electrode, Electrocardiograph |
| Applicant | R & D MEDICAL PRODUCTS, INC. 20492 CRESCENT BAY DR. #106 Lake Forest, CA 92630 |
| Contact | James Perrault |
| Correspondent | James Perrault R & D MEDICAL PRODUCTS, INC. 20492 CRESCENT BAY DR. #106 Lake Forest, CA 92630 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2009-12-10 |
| Summary: | summary |