510(k) K062754 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
GAS MODULE SE, MODEL 0998-00-0481-02
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Nov 2, 2006 |
| Received | Sep 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2017 | Mindray DS USA, Inc. dba Mindray North America Gas Module 3 monitoring spirometer, Part Number: 115-030108-00
Product Usage:
The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. M Terminated |
BZK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.