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 |