The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Bio-detek Modified Adult Multi-function Electrode With Connector.
Device ID | K033771 |
510k Number | K033771 |
Device Name: | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
Contact | Robert Morse |
Correspondent | Robert Morse BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-03 |
Decision Date | 2004-02-27 |
Summary: | summary |