Data / Medical devices / United States / Defibtech North Branford
Defibtech North Branford: FDA-registered device maker in North Branford, CT, United States, 2 510(k) clearances and 1 PMA approval
Defibtech North Branford is registered with the FDA (registration 3026976873) in North Branford, CT, United States. It lists 2 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated November 9, 2021. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3026976873
- Address
- 21 Commerce Dr, North Branford, CT, United States, 06471
- Owner or operator
- DEFIBTECH, LLC (9048526)
- Roles
- Manufacturer
- First device listed
- October 30, 2014
- Registered through
- 2027
- Brand names listed
- DBP-1400 5-year non-rechargeable battery pack, DBP-2003 4-year non-rechargeable battery pack, DBP-2013 4-year non-rechargeable TSO battery, DBP-2800 7-year non-rechargeable battery pack, DDP-100 Adult Defibrillation Pads, DDP-2001 Adult Defibrillation Pads, DDP-2002 Pediatric Defibrillation Pads, DDP-200P Pediatric Defibrillation Pads and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Manufacturer | accessdata.fda.gov |
| Compressor, Cardiac, External | DRM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2021 | K211289 | RMU-2000 Automated Chest Compression System | DRM | Substantially Equivalent | Defibtech, LLC | accessdata.fda.gov |
| October 27, 2014 | K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | DRM | Substantially Equivalent | Defibtech, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 1, 2018 | P160032 | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- | MKJ | 17 | August 25, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Compressor, Cardiac, External
- All makers of Automated External Defibrillators (Non-Wearable)
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.