510(k) K151954 ยท BSZ Gas-Machine, Anesthesia
A7 Anesthesia System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 27, 2015 |
| Received | Jul 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)
Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a Terminated |
BSZ | None listed |
| Aug 4, 2016 | Beckman Coulter Inc. UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222
UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer Terminated |
BSZ | None listed |
| Jun 15, 2016 | Mindray DS USA, Inc. dba Mindray North America A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.