The following data is part of a premarket notification filed by Ad Elektronik Gmbh with the FDA for Mobile Battery Service Station (mbss).
Device ID | K030898 |
510k Number | K030898 |
Device Name: | MOBILE BATTERY SERVICE STATION (MBSS) |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | AD ELEKTRONIK GMBH 33 STEEPLECHASE DR. Tunersville, NJ 08012 |
Contact | Richard Tootchen |
Correspondent | Richard Tootchen AD ELEKTRONIK GMBH 33 STEEPLECHASE DR. Tunersville, NJ 08012 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-21 |
Decision Date | 2003-08-27 |
Summary: | summary |