Change to the manufacturing test limit acceptance criteria on two test stations (base functional test and system functional test) for the defibtech ddu-100 series and ddu-2000 series aeds.
| Device | Defibtech Automated External Defibrillator (AED) Systems |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | DEFIBTECH, LLC |
| Date Received | 2018-11-09 |
| Decision Date | 2018-12-06 |
| PMA | P160032 |
| Supplement | S001 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEFIBTECH, LLC 741 Boston Post Road suite 201 guilford, CT 06437 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160032 | | Original Filing |
| S010 |
2021-06-14 |
Real-time Process |
| S009 |
2020-07-27 |
Real-time Process |
| S008 |
2020-07-21 |
Real-time Process |
| S007 |
2020-05-26 |
30-day Notice |
| S006 |
2020-05-08 |
30-day Notice |
| S005 | | |
| S004 |
2020-01-27 |
Real-time Process |
| S003 | | |
| S002 | | |
| S001 |
2018-11-09 |
30-day Notice |
NIH GUDID Devices