The following data is part of a premarket notification filed by Dowit Service Co., Inc. with the FDA for Battery Packs For Cardiovascular Units.
| Device ID | K881643 |
| 510k Number | K881643 |
| Device Name: | BATTERY PACKS FOR CARDIOVASCULAR UNITS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DOWIT SERVICE CO., INC. P.O. BOX 433 Towaco, NJ 07082 |
| Contact | Joan Potosnak |
| Correspondent | Joan Potosnak DOWIT SERVICE CO., INC. P.O. BOX 433 Towaco, NJ 07082 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-05-17 |