510(k) K221700 ยท DRM Compressor, Cardiac, External
AutoPulse NXT Resuscitation System
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Mar 9, 2023 |
| Received | Jun 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | ZOLL Circulation, Inc. Brand Name: AutoPulse NXT Resuscitation System
Product Name: AutoPulse NXT Platform
Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)
Software Version: Version 2.0.1
Product Description: Open, Classified |
DRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.