The following data is part of a premarket notification filed by Energy Concepts, Inc. with the FDA for Replacement Batteries For Medical Instrumentation.
| Device ID | K872476 |
| 510k Number | K872476 |
| Device Name: | REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ENERGY CONCEPTS, INC. P.O. BOX 128 5205 D AVENIDA ENCINAS Carlsbad, CA 92008 |
| Contact | Donald S Diehl |
| Correspondent | Donald S Diehl ENERGY CONCEPTS, INC. P.O. BOX 128 5205 D AVENIDA ENCINAS Carlsbad, CA 92008 |
| Product Code | MHX |
| Subsequent Product Code | DQI |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-09-21 |